MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM BALL HEAD IMPACTOR

Model Number	75023710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr procedure the polarstem ball head impactor broke while impaction inside the patient.Surgery was completed with a change in the surgical technique.No surgical delays were reported.
Additional Manufacturer Narrative
Investigation results: it was reported that during a thr procedure the polarstem ball head impactor (75023710) broke while impaction inside the patient.The device intended for use during treatment was not returned for investigation nor was the batch number communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not be confirmed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The ifu (lit.No.12.23 ed 05/16) requires that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on the limited information provided, a thorough medical assessment could not be performed.Based on available information, the reported failure mode cannot be confirmed and the root cause stays undetermined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the device or additional information be received.

• Brand Name: POLARSTEM BALL HEAD IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10815706
• Report Number: 9613369-2020-00233
• Device Sequence Number: 13928662
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2021

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: 75023710
• Device Catalogue Number: 75023710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention