MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0090
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
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
Customer reports a gamma3 targeting device that can't be detached from the gamma3 nail.The nail was properly connected to the targeting device for implantation of a gamma nail (180 length).At the end of the surgery, the retaining screw could not be loosened.As a result, it was necessary to remove the entire gamma nail and re-implant a new gamma nail with a replacement instrument set.
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 device was received in stuck state.After disassembling of the device with special apparatus, screw shows residual blood on its surface.After decontamination, the screw surfaces shows no appearance of damage or breakage.Surface of the device looks good for use.The functional test was performed with returned nail, target device and nail holding screw.After disassembling them from the initial state, the device was found to be fully functional.The device could be assembled and disassembled without any issues.No jam issue encountered again.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 the above investigation, the root cause of the issue is most likely user related.The device shows appearance of blood residual on its surfaces, which potentially caused overtightening of the nail in between the interface of the nail and the screw.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reports a gamma3 targeting device that can't be detached from the gamma3 nail.The nail was properly connected to the targeting device for implantation of a gamma nail (180 length).At the end of the surgery, the retaining screw could not be loosened.As a result, it was necessary to remove the entire gamma nail and re-implant a new gamma nail with a replacement instrument set.

• Brand Name: NAIL HOLDING SCREW GAMMA3 8X35MM
• 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
• MDR Report Key: 12166749
• Report Number: 0009610622-2021-00594
• Device Sequence Number: 4052865
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 Model Number: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: KSS19808E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1