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
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while reaming the calcar by using the calcar reamer, the femoral bone was broken.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2019-00054
• Device Sequence Number: 16534353
• Product Code: KWY
• UDI-Device Identifier: 00885556535516
• UDI-Public: 00885556535516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 75102207
• Device Lot Number: A61245
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART:75102205,COLLAR REAMER GUIDE,LOT:UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization