MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR CALCAR REAMER SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75102207
Medical Device Problem Codes	Dull, Blunt (2407); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery the polarstem collar calcar reamer small was dull and fractured patient´s calcar.The procedure was completed, without delay.
Additional Manufacturer Narrative
H3, h6: it was reported that during a total hip replacement surgery the polarstem collar calcar reamer small was dull and fractured patient´s calcar.The device, used in treatment, was returned for investigation and a visual inspection was performed.The returned instrument is in a good condition and only slight signs of use such as superficial scratches are observed.The cutting teeth are still very sharp.A review of the complaint history of the affected device was performed.Two additional complaints for the batch in scope were detected with a similar reported failure mode.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of past corrective actions was performed.No further escalation is required.A risk management review for bone fracture in combination with the use of a calcar reamer was performed within a preliminary risk assessment in aug.2021.According to this, the performance of the device is within the risks that are anticipated in the risk management documentation of the product, both in occurrence and severity.As no medical documents have been provided regarding the femoral bone fracture, no review could be conducted.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The calcar reamer device has been observed to lead in some rare cases to calcar fracture.There is another instrument with shorter teeth, that may be more appropriate to the expectation of the surgeon.Based on the performed investigations, the relationship between the reported event and the device could be confirmed.Nevertheless, the root cause of the reported intra-operative calcar 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.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at this time.The continued performance of the device shall be monitored through standard post market surveillance review processes.Smith and nephew will continue to monitor this device for similar issues.The returned part will be discarded.

• Brand Name: POLARSTEM COLLAR CALCAR REAMER SMALL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14140477
• Report Number: 9613369-2022-00217
• Device Sequence Number: 6371909
• Product Code: LXH
• UDI-Device Identifier: 00885556535516
• UDI-Public: 00885556535516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75102207
• Device Catalogue Number: 75102207
• Device Lot Number: A61245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown