MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR PART FOR HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023346
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the polarcup impactor part for handle broke during procedure, while instruments were outside the patient.It is unknown how the procedure was completed.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
It was reported that the polarcup impactor part for handle (75023346) broke during the procedure.However, no surgical delay or injury to the patient was reported.The part, used in treatment, was returned for investigation.The part fractured into two pieces.Furthermore, the part shows signs of use.The production documentation was reviewed.There was no deviation found, which would explain the issue.No further complaint with the same failure mode was reported for the batch in scope.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 received instrument is designed to reposition the polarcup shell.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The observed failure could not be reproduced.Based on the conducted investigations the root cause of the fracture could therefore not be determined conclusively.Nonetheless, in combination with our continuous effort to improve our products, design changes have been implemented to enhance the mechanical behaviour of this device.Smith and nephew will monitor this device for further similar issues.The returned device will be discarded.

• Brand Name: POLARCUP IMPACTOR PART FOR HANDLE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11580495
• Report Number: 9613369-2021-00130
• Device Sequence Number: 11807708
• Product Code: LPH
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 75023346
• Device Catalogue Number: 75023346
• Device Lot Number: 21000621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1