MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø9,5X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 02276095

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The flexible reamer was bent slightly during reaming the femoral bone marrow cavity by a rasp and a flexible reamer.It was rotated reverse accidentally.Procedure was completed successfully with no surgical delay or adverse consequences reported.

Event Description

The flexible reamer was bent slightly during reaming the femoral bone marrow cavity by a rasp and a flexible reamer.It was rotated reverse accidentally.Procedure was completed successfully with no surgical delay or adverse consequences reported.

Manufacturer Narrative

The reported event could be confirmed.Visual inspection revealed the following: the received bixcut im reamer was observed deformed at the spiral shaft near the adapter.Coil of the flexible shaft was a bit deformed and squeezed near breaking point, most likely due to torsional overload in the reverse direction during the insertion time.The cutting edge also appears blunt.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to an improper usage of the reamer as it was operated in an anti-clockwise manner which is an off-label use.Consequently, the spiral at the proximal part of the reamer got caught in the bone and was damaged.If any further information is provided, the complaint report will be updated.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø9,5X480MM
• Type of Device: 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: 9216443
• MDR Text Key: 191687088
• Report Number: 0009610622-2019-00876
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540145833
• UDI-Public: 04546540145833
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02276095
• Device Lot Number: K025065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1