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

Catalog Number	18060110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2019
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
The stryker rep reported they were supporting a case where the surgeon was using the universal rod and reduction.The surgeon applied a lot of force through a hammer which caused the device to break.The spoon part of the instruments broke away from the rod, leaving it in the femoral canal.The spoon was retrieved by opening the femur at the fracture site, and the rep reported that this would of had to be carried out to reduce the fracture anyway.Slight delay, no more than 5 minutes.
Event or Problem Description
The stryker rep reported they were supporting a case where the surgeon was using the universal rod and reduction.The surgeon applied a lot of force through a hammer which caused the device to break.The spoon part of the instruments broke away from the rod, leaving it in the femoral canal.The spoon was retrieved by opening the femur at the fracture site, and the rep reported that this would of had to be carried out to reduce the fracture anyway.Slight delay, no more than 5 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by rough handling.The device inspection revealed the following: 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.Furthermore, hammer signs were found on the handle surface.The broken off part was returned as well and was found to be stuck in the counterpart, which was returned as well.The breakage surfaces show the typically structure of a brittle fracture, which is supported by the event description ¿the surgeon applied a lot of force through a hammer which caused the device to break.¿ 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.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.

• 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
• MDR Report Key: 8429110
• Report Number: 0009610622-2019-00111
• Device Sequence Number: 239261
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 05/03/2019

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 Catalogue Number: 18060110
• Device Lot Number: K797491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR