Speed Shift SE-2020-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810633020494), received between Mar 17, 2022 and Feb 14, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 27, 2022Open, Classified

   The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

   Z-0098-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Break; Break

  THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373598 ↗
• MalfunctionNov 28, 2022Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN SET INSPECTION AT DC ON (B)(6) 2022, THE BONE STAPLE WAS BROKEN INSIDE THE ORIGINAL PACKAGING. THE DEFECT WAS NOTICED THROUGH THE VIEWING WINDOW. THIS REPORT IS FOR A SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874048 ↗
• MalfunctionOct 18, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. THESE WERE FOUND IN IN INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 20X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625121 ↗
• MalfunctionOct 18, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. LOT NUMBER MSE210237. THESE WERE FOUND IN INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 20X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625020 ↗
• MalfunctionOct 13, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. LOT NUMBER MSE210237. THESE WERE FOUND IN OUR INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600926 ↗
• MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6)2022 IN THE CHAMPAIGN IL SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10 THIS IS REPORT 3 OF 3 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418833 ↗
• MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, IN THE CHAMPAIGN IL SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418827 ↗
• MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, IN THE (B)(6) SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418820 ↗
• MalfunctionAug 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PRODUCT CODE (B)(4), THE WRONG DRILL GUIDE WAS PACKAGED WITH THE PRODUCT. THE 15-06 DRILL GUIDE, TO BE USE WITH (B)(4), WAS PACKAGED WITH THE PRODUCT. THERE WERE NO SURGICAL DELAY . PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 1 FOR (B)(4).COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297549 ↗
• MalfunctionMar 17, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SPEED SHIFT IMPLANT KIT WAS DISCOVERED BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792128 ↗