MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM MODULAR HEAD FOR 21000662; IMPACTOR

Catalog Number 75023711

Device Problem Material Rupture (1546)

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

Event Date 11/09/2018

Event Type  malfunction  

Event Description

The instrument broke during surgery.A broken plastic part fell into the surgical wound, but could be recovered by the surgeon.The surgery time was extended due to this problem about 8 minutes.A backup instrument was available, the surgery was finished successfully.No harm to patient.

Manufacturer Narrative

Results of investigation: a polarstem modular head for 21000662 has been returned for investigation.Review of the production documentation including the material certificate did not reveal any deviation from standard operating procedure.Visual inspection confirmed the reported fracture.One piece from the contact area to the ball head fractured.This fracture pattern has been observed in the past in some cases.The root cause of the fracture could however, not be determined conclusively in this specific case.A design change has been performed to reduce the occurrence of similar issues.Smith & nephew will continue to monitor for similar issues.

• Brand Name: POLARSTEM MODULAR HEAD FOR 21000662
• Type of Device: IMPACTOR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8149572
• MDR Text Key: 130032004
• Report Number: 9613369-2018-00085
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611996114393
• UDI-Public: 07611996114393
• Combination Product (y/n): N
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75023711
• Device Lot Number: A52937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other