MAUDE Adverse Event Report: STRYKER GMBH SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0066
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a short gamma3 nail was removed to implant a hip prosthesis.When removing the end cap, the distal screwdriver head of the instrument broke off.Our loaner kit was used for the extraction.Another set of instruments had to be ordered from another hospital, which resulted in a surgical delay of almost 60 minutes." aj (b)(6) 2023, rep confirmed that the nail was intact and it was only removed as patient required full prosthesis.Kt (b)(6) 2023: rep confirmed that the reason for the conversion was a hip joint arthrosis and that the surgeon was able to complete the surgery successfully after getting an additional instrument kit from another hospital.Rep further confirmed that the broken tip of the instrument was removed from the patient and that all (three) parts were already returned to the manufacturer.
Event or Problem Description
As reported: "a short gamma3 nail was removed to implant a hip prosthesis.When removing the end cap, the distal screwdriver head of the instrument broke off.Our loaner kit was used for the extraction.Another set of instruments had to be ordered from another hospital, which resulted in a surgical delay of almost 60 minutes." according to additional information received the rep confirmed that the nail was intact and it was only removed as patient required full prosthesis.Further, the rep confirmed that the reason for the conversion was a hip joint arthrosis and that the surgeon was able to complete the surgery successfully after getting an additional instrument kit from another hospital.The rep further confirmed that the broken tip of the instrument was removed from the patient and that all (three) parts were already returned to the manufacturer.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device exhibit signs of extreme usage over a long period of time.Scratches and dents marks can be seen on the proximal head and on the body.The broken distal tip shows deformation signs due to long usage.The breakage indicates towards application of high torsional load and sudden overloading resulting in brittle fracture at the distal end which can be seen in the microscopic image.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by overloading on the device during usage which caused sudden brittle fracture.Also, since the device was manufactured in 2013, it is plausible that weakened structural integrity due to frequent usage and reprocessing cycles (wear and tear) may have also contributed to the breakage, therefore it is safe to say that it had fulfilled its tasks in former surgeries as intended as there is no prior complaint reported with the same lot.If any further information is provided, the complaint report will be updated.

• Brand Name: SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 16684056
• Report Number: 0009610622-2023-00099
• Device Sequence Number: 15260403
• Product Code: LXH
• UDI-Device Identifier: 04546540487667
• UDI-Public: 04546540487667
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/18/2023

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: 1320-0066
• Device Catalogue Number: 13200066
• Device Lot Number: K02AD37
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2013
• 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 Sex: Unknown