MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	02276080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
During intramedullary nail surgery, the reamer shaft unraveled in the patient bone because the surgeon turned the power tool backwards.The reamer shaft was removed from the patient without problem.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by not following the operative technique guide.The operative technique guide states: "flexible reamers should always be used over a ball tip guide wire.The ball tip at the end of the guide wire will prevent the reamer head to advance beyond the medullary canal.Caution: where the bone is comminuted, reaming should be stopped at the fracture site and the reamers advanced with the power drill off." if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During intramedullary nail surgery, the reamer shaft unraveled in the patient bone because the surgeon turned the power tool backwards.The reamer shaft was removed from the patient without problem.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8804880
• Report Number: 0009610622-2019-00547
• Device Sequence Number: 14168075
• Product Code: LPH
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• 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): 09/26/2019

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: 02276080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR