Baby Gorilla/Gorilla Plating System P99-191-TR10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889795041326), received between Jan 26, 2026 and Sep 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fracture

  It was reported that a recon screwdriver tip broke during an (b)(6) ankle procedure. During the procedure, no fragments or components fell into the patient, and the surgery was completed using a secondary screwdriver available as backup. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752407 ↗
• MalfunctionMay 29, 2026Fracture

  IT WAS REPORTED THAT A SCREW DRIVER BROKE DURING A PROCEDURE. ALL DEBRIS WAS REMOVED FROM THE PATIENT. THE EVENT CAUSED A DELAY OF 5-10 MINUTES WITH NO CONSEQUENCES OR IMPACT TO THE PATIENT. A DIFFERENT DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL SURGICAL COMPLICATIONS NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337579 ↗
• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT DURING AN ANKLE ORIF, THE SCREWDRIVER TIP BROKE WHILE THE SURGEON WAS TIGHTENING A SCREW. THE DEBRIS WAS REMOVED FROM THE PATIENT, AND A DIFFERENT INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL INTERRUPTIONS. THE PATIENT HAD NO KNOWN IMPACT OR CONSEQUENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035466 ↗
• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT DURING A PRIMARY METATARSOPHALANGEAL (MTP) ARTHRODESIS, A SCREWDRIVER TIP FRACTURED DURING THE FINAL TIGHTENING OF A LOCKING SCREW. AS THE FINAL STEP OF THE PROCEDURE, WHEN TIGHTENING THE LAST SCREW IN THE PLATE, THE DRIVER TIP BROKE. THE SCREWDRIVER WAS REPLACED, AND DURING FINAL TIGHTENING OF THE SAME SCREW, THE REPLACEMENT DRIVER TIP ALSO FRACTURED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033933 ↗
• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT DURING A PRIMARY METATARSOPHALANGEAL (MTP) ARTHRODESIS, A SCREWDRIVER TIP FRACTURED DURING THE FINAL TIGHTENING OF A LOCKING SCREW. AS THE FINAL STEP OF THE PROCEDURE, WHEN TIGHTENING THE LAST SCREW IN THE PLATE, THE DRIVER TIP BROKE. THE SCREWDRIVER WAS REPLACED, AND DURING FINAL TIGHTENING OF THE SAME SCREW, THE REPLACEMENT DRIVER TIP ALSO FRACTURED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033920 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, AN HX10 SCREWDRIVER BROKE WHILE INSERTING A SCREW INTO AN FTMTJ PLATE. SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. THE PATIENT'S BONE WAS NOT HARD, AND THE APPROPRIATE DRILL WAS USED. THE BROKEN FRAGMENT WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE INSTRUMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912011 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT DURING FIXATION OF A FIBULA PLATE, A SCREWDRIVER BROKE WHILE INSERTING A SCREW. THE BROKEN PORTION WAS REMOVED INTRA-OPERATIVELY AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO CONSEQUENCES OR IMPACT TO THE PATIENT. DELAY OF SURGERY WAS LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627353 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF DURING THE CASE. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE CASE WITH A SURGERY DELAY OF LESS THAN 30 MINUTES. ALL DEBRIS WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491608 ↗
• MalfunctionJan 26, 2026Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF DURING THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182466 ↗