Innomed, Inc. 3645-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840277105943), received between May 3, 2017 and Dec 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PT. HAD REVERSE TOTAL SHOULDER SURGERY. SURGERY WAS COMPLETED AND PATIENT TAKEN TO PACU. THE INSTRUMENTS FOR THE CASE WAS TAKEN TO DECONTAMINATION, WHERE THE SPD EMPLOYEE WASHING THE INSTRUMENT NOTICED A PIECE MISSING FROM A PITUITARY RONGEUR. PHYSICIAN RESPONDED THAT HE SAW THE X-RAY AND THE PIECE OF METAL. NOTED SHOULDN'T BE A PROBLEM NOW. HE PLANS TO RE X-RAY AT HIS POST APPOINTMENT TO SEE IF THE PIECE HAD MOVED WHICH WAS DETERMINED TO BE A PIECE OF THE PITUITARY RONGEUR. THE PATIENT WAS SENT HOME, AND IT APPEARS THE SMALL PIECE LEFT IN THE SHOULDER SHOULD NOT BE PROBLEM, BUT WILL BE MONITORED ON FUTURE APPOINTMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053757 ↗
• MalfunctionNov 30, 2022Break; Entrapment of Device

  PT HAD REVERSE TOTAL SHOULDER SURGERY. SURGERY WAS COMPLETED AND PATIENT TAKEN TO PACU. THE INSTRUMENTS FOR THE CASE WERE TAKEN TO DECONTAMINATION, WHERE THE SPD EMPLOYEE WASHING THE INSTRUMENTS NOTED A PIECE MISSING FROM A PITUITARY RONGUER. PHYSICIAN RESPONDED THAT HE SAW THE X-RAY AND THE PIECE OF METAL; NOTED SHOULDN'T BE A PROBLEM NOW. HE PLANS TO RE-X-RAY AT HIS POSTOP APPOINTMENT TO SEE IF THE PIECE HAD MOVED WHICH WAS DETERMINED TO BE A PIECE OF THE PITUITARY RONGUER. THE PATIENT WAS SENT HOME AND IT APPEARS THE SMALL PIECE LEFT IN SHOULDER SHOULD NOT BE A PROBLEM BUT WILL BE MONITORED ON FUTURE APPOINTMENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15893712 ↗
• MalfunctionMay 3, 2017Break; Break

  THE FOLLOWING DESCRIPTION WAS RECEIVED BY THE CDRH ON (B)(6) 2017 WITH THE ASSIGNED MDR REPORT KEY 6259585: APPROXIMATELY 1MM PART OF A 3MM SPIKE WAS GONE AT THE END OF SURGERY. RESPONSE: THIS EVENT WAS INITIALLY RECEIVED AS A COMPLAINT ON (B)(6) 2015. IT IS DOCUMENTED IN INNOMED'S INTERNAL COMPLAINTS DATABASE. A THOROUGH EXAMINATION ENSUED, AND A ROOT CAUSE WAS ESTABLISHED. CORRECTIVE AND PREVENTIVE ACTIONS WERE IMPLEMENTED TO FIX THE DESCRIBED ISSUE, AND PREVENT ITS RECURRENCE. CONTAINMENT ACTIVITIES WERE ALSO PERFORMED. A COPY OF THE INVESTIGATIVE REPORT WAS FORWARDED TO THE CONTACT. THE CONTACT NEVER RESPONDED. MEDWATCH FORM 3500A WAS RECEIVED AT INNOMED ON JAN. 23RD WITH THE SAME DESCRIPTION AS ABOVE. THE INITIAL REPORTER IDENTIFIED ON THE FORM WAS PHONED AND EXPLAINED THAT INNOMED HAD PREVIOUSLY RECEIVED THE SAME COMPLAINT FROM THE SAME USER FACILITY REGARDING THE SAME DEVICE AND LOT NUMBER. THE COMPLAINT WAS ADDRESSED WITH THE AFOREMENTIONED ACTIONS AND FOLLOW UP ACTIVITIES WERE PERFORMED. THE INITIAL REPORTER AT THE TIME DID NOT RESPOND TO THE RESULTS OF THE INVESTIGATION. THE CURRENT INITIAL IMPORTER RELAYED THAT A FOLLOW UP RESPONSE TO THE RELAYED INFORMATION WOULD BE COM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541381 ↗