MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NUT T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3213
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "in practice, the nut remained locked to the nail adapter block.Therefore we had to interrupt the operation, because it was no longer possible to connect the centering device.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d4 lot#.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 shows signs of normal usage, evident by worn-off surfaces and scratches.However, it was observed that the first couple of threads were found to be deformed.The underside of the nut also had hitting marks, indicating abnormal usage.A functional inspection was carried out and it was found that the nut and the nail adapter were jammed together and cannot be unscrewed because the proximal head of the nail adapter on which the nut was screwed was bent from the unwanted external impact as evident from the provided pictures due to which their threads got misaligned and jammed together.For the nut to be unlocked the nail adapter proximal head was straightened and after that, the nut can be easily unlocked from the nail adapter leaving damaged threads on both the devices.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 investigation, the root cause was attributed to a user-related issue.The failure was caused by the mishandling of the devices which resulted in the bending of the proximal head of the nail adapter causing the two devices¿ threads to get misaligned and stuck together.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "in practice, the nut remained locked to the nail adapter block.Therefore we had to interrupt the operation, because it was no longer possible to connect the centering device.".

• Brand Name: NUT T2 ANKLE
• 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: 15117109
• Report Number: 0009610622-2022-00347
• Device Sequence Number: 5619111
• Product Code: LXH
• UDI-Device Identifier: 04546540708502
• UDI-Public: 04546540708502
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806-3213
• Device Catalogue Number: 18063213
• Device Lot Number: K614572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown