MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. POLARSTEM COLLAR CLACAR REAMER SMALL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75102207

Device Problem Human-Device Interface Problem (2949)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/16/2019

Event Type  Injury  

Event Description

It was reported that during surgery, while reaming the calcar by using the calcar reamer, the femoral bone was broken.

Manufacturer Narrative

It was reported that while reaming with the calcar reamer, the femoral bone broke.The affected reamer guide and the corresponding calcar reamer were returned for investigation.The returned instruments are in a good condition and only slight wear patterns are observed.A functional evaluation performed with the returned two devices showed, that once the reamer guide is mounted on a rasp, the calcar reamer can freely spin around the reamer guide.As no medical documents have been provided, regarding the femoral bone fracture, no review could be conducted.Based on the performed investigation, the root cause of the reported intra-operative femoral fracture cannot be determined conclusively.It is however recommended, to first bring the reamer in motion/spinning before touching down on the bone for reaming.The continued performance of the device shall be monitored through standard pms review processes.Smith&nephew will continue to monitor this device for similar issues.The returned parts will be archived.

• Brand Name: POLARSTEM COLLAR CLACAR REAMER SMALL
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8899760
• MDR Text Key: 154539171
• Report Number: 9613369-2019-00054
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00885556535516
• UDI-Public: 00885556535516
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75102207
• Device Lot Number: A61245
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART:75102205,COLLAR REAMER GUIDE,LOT:UNKNOWN
• Patient Outcome(s): Hospitalization