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

Model Number	1320-0090
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
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: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".
Event or Problem Description
As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - device not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13388699
• Report Number: 0009610622-2022-00035
• Device Sequence Number: 14667050
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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