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

Model Number	1320-0090
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported to the (b)(6) that : "the incident occurred during the intervention with a gamma nail once the gamma nail was installed, it was impossible to unscrew the nail from the target device.It was necessary to repeat the whole procedure with another instrument panel and once the nail was extracted from the target device, the locking was complete and it was still impossible to unscrew it.The unlocking had to be done in sterilization.The extracted nail has been quarantined with the target device, a replacement of the nail port has been requested".
Additional Manufacturer Narrative
The reported event could not be confirmed.Visual inspection: no signs of significant damage and no evidence of rough handling found.A functional inspection showed that the nail could be assembled and disassembled with the nhs to the target device successfully; all products were found fully functional.The alleged event could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.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 a root cause could not be determined.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported to the ansm that : "the incident occurred during the intervention with a gamma nail once the gamma nail was installed, it was impossible to unscrew the nail from the target device.It was necessary to repeat the whole procedure with another instrument panel and once the nail was extracted from the target device, the locking was complete and it was still impossible to unscrew it.The unlocking had to be done in sterilization.The extracted nail has been quarantined with the target device, a replacement of the nail port has been requested.

• 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; DE D-24232
• MDR Report Key: 9527440
• Report Number: 0009610622-2019-00998
• Device Sequence Number: 411772
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: KSS156539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1