MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD T2 FEMUR 9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
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
As reported: the threaded end of the universal rod was broken, and the broken part was caught in the extraction adapter.The nurse noticed before the operation.Using other instruments, the operation ended without problems.If the nurse didn't notice and there was no substitute, it was a big problem.There is a problem with the inspection method.
Event or Problem Description
As reported: the threaded end of the universal rod was broken, and the broken part was caught in the extraction adapter.The nurse noticed before the operation.Using other instruments, the operation ended without problems.If the nurse didn't notice and there was no substitute, it was a big problem.There is a problem with the inspection method.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.As per the visual inspection, the threads of the universal rod were found to be damaged.The device was manufactured in 2001, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.No indications of material, manufacturing or design related problems were found during the investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Based on the above investigation the root cause of the failure is found to be normal wear.If any additional information is provided, the investigation will be reassessed.

• Brand Name: UNIVERSAL ROD T2 FEMUR 9 MM
• 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: 10203068
• Report Number: 0009610622-2020-00302
• Device Sequence Number: 16411932
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• 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): 09/02/2020

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: 1806-0110
• Device Catalogue Number: 18060110
• Device Lot Number: K865228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1