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

Model Number 75023710

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2020

Event Type  Injury  

Event 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.

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
• Type of Device: IMPACTOR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10815706
• MDR Text Key: 215472376
• Report Number: 9613369-2020-00233
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75023710
• Device Catalogue Number: 75023710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention