MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER SHAFT AO, SHORT T2 TIBIA 3,5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision of the patient's left proximal humerus, the surgeon attempted to remove the proximal locking screws using the teardrop handle and short screwdriver shaft despite being told that was not the correct instrument to use.The connection snapped inside the adapter.All parts were removed and the correct instrument was used to remove the screws.Surgery was completed successfully with no delay.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that during a revision of the patient's left proximal humerus, the surgeon attempted to remove the proximal locking screws using the teardrop handle and short screwdriver shaft despite being told that that was not the correct instrument to use.The connection snapped inside the adapter.All parts were removed and the correct instrument was used to remove the screws.Surgery was completed successfully with no delay.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device shows no sign of matching the alleged failure and was found to be fully functional.The screwdriver shaft that was received doesn't show any visible sign of damage marks on the proximal side, on the contrary, the distal side indicates assembly and disassembly marks that were caused by using an off-label device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs the user that: ¿off-label use of an instrument can harm the patient and/or impair the function and integrity of the instrument.¿ based on the investigation the root cause of the failure was determined to be user related.I.E., off-label product usage.If any additional information is provided, the investigation will be reassessed.

• Brand Name: SCREWDRIVER SHAFT AO, SHORT T2 TIBIA 3,5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12982649
• Report Number: 0009610622-2021-00817
• Device Sequence Number: 20247962
• Product Code: LXH
• UDI-Device Identifier: 04546540353245
• UDI-Public: 04546540353245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 03/15/2022

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 Model Number: 1806-0222
• Device Catalogue Number: 18060222
• Device Lot Number: K771429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female