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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2020
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
It was reported, when the u-blade adapter was manually attached to the universal rod, the threaded portion at the end of the universal rod was damaged, and the broken piece was caught in the u-blade adapter, making it unusable.Instruments in the hospital were sterilized and used.
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 thread of the universal rod was found completely broken off.The last windings are broken, traces of significant use are also visible on the surface of universal rod t2 femur ø9 mm.Based on the above investigation the root cause of the failure is found to be normal wear.Referring to the very long period since manufacturing [manufactured in 2004] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, when the u-blade adapter was manually attached to the universal rod, the threaded portion at the end of the universal rod was damaged, and the broken piece was caught in the u-blade adapter, making it unusable.Instruments in the hospital were sterilized and used.

• 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: 10073175
• Report Number: 0009610622-2020-00250
• Device Sequence Number: 11420260
• 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): 07/29/2020

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: K797546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1