MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE SLEEVE GAMMA3® Ø10.5X268MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200150
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
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
It was reported that, during a primary procedure on a right femur, when drilling the k-wire trocar through the trocar sleeve, the k-wire became stuck in the sleeve and could not be removed intra-operatively.The construct was removed and another sleeve was used with another k-wire to complete the procedure successfully with a surgical delay of approximately 5-10 minutes.No adverse consequences reported.
Event or Problem Description
It was reported that, during a primary procedure on a right femur, when drilling the k-wire trocar through the trocar sleeve, the k-wire became stuck in the sleeve and could not be removed intra-operatively.The construct was removed and another sleeve was used with another k-wire to complete the procedure successfully with a surgical delay of approximately 5-10 minutes.No adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received guidewire sleeve shows typical signs of intense and frequent uses.Significant imprints and hammering marks are found on the surface of the head of the sleeve near the entry bore for k-wire.In case of intended use, such damage would not have occurred.The damage pattern reveals that the device had been long in use which caused internal material degradation.Also, the head portion of the sleeve reveals that it has been hammered in previous surgeries as well.This is an off-label usage which caused further deterioration of the device.In order to reproduce the reported event a functional test was performed with a sample 3.2 mm k-wire, which revealed that the k-wire did not pass through the sleeve because the internal surface of the hole was deformed.Based on the investigation the root cause was attributed to a user related issue.The above investigation revealed that the k-wire could not pass through the sleeve due to the deformation of the entry point of the sleeve caused due to a combination of normal wear and mishandling by the user in the former surgeries.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The device had been in use for a long time (manufactured in 2010), therefore it can be safely said that it had fulfilled its tasks in former surgeries as intended.A review of the labeling did not indicate any abnormalities.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GUIDE WIRE SLEEVE GAMMA3® Ø10.5X268MM
• 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: 8900784
• Report Number: 0009610622-2019-00614
• Device Sequence Number: 16644448
• Product Code: LXH
• UDI-Device Identifier: 04546540377753
• UDI-Public: 04546540377753
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 13200150
• Device Lot Number: K256978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1