MAUDE Adverse Event Report: STRYKER GMBH STERILE FIELD KIT HOFFMANN 3 KIT B; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4922-9-941S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when i used the drill brace and inserted the apex pin, a piece of metal came out of the drill brace.The operation continued as it was and was completed without any problems.".
Additional Manufacturer Narrative
The reported event could not be confirmed since no debris were found on the device.The visual inspection showed that the device is in a good state overall.No major damage was noticed.However, the surface of the pin's head is slightly damaged.Probably, high forces were applied while using the instruments.Therefore, the debris reported in the complaint may be generated by the damage of the rod.However, the functional inspection showed that the device is fully functional and that no debris were generated or found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was most probably caused by a mishandling of the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "when i used the drill brace and inserted the apex pin, a piece of metal came out of the drill brace.The operation continued as it was and was completed without any problems.".

• Brand Name: STERILE FIELD KIT HOFFMANN 3 KIT B
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10781535
• Report Number: 0008031020-2020-02423
• Device Sequence Number: 1061549
• Product Code: KTT
• UDI-Device Identifier: 07613327008005
• UDI-Public: 07613327008005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2024
• Device Model Number: 4922-9-941S
• Device Catalogue Number: 49229941S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1