MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD T2 FEMUR Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
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, during the surgery when inserting a femoral nail, the rod was placed on the insertion handle in order to reposition the nail somewhat proximally.When the nail was knocked out, the entire thread was torn out.The surgery could be finished without any problems.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: a universal rod t2 femur ø9 mm was received for evaluation.The returned device shows traces of a high frequently usage.The thread of the universal rod was found completely broken off.It broke at the last windings.The breakage surfaces show a smooth structure.Plastic deformation along the breakage surfaces is not found.The broken off part was returned as well.The breakage surfaces show the typically structure of a brittle fracture, most likely due to a bending overload.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate handling.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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported, during the surgery when inserting a femoral nail, the rod was placed on the insertion handle in order to reposition the nail somewhat proximally.When the nail was knocked out, the entire thread was torn out.The surgery could be finished without any problems.

• Brand Name: UNIVERSAL ROD T2 FEMUR Ø9 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: 9787956
• Report Number: 0009610622-2020-00088
• Device Sequence Number: 11425603
• 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): 06/01/2020

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: K724577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1