MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000649
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the adapter broke during implant impaction.A change in surgical technique was required in order to complete the procedure.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that the polarcup handle adapt.22mm trial insert (75000649) broke during implant impaction.The device used during treatment was returned for investigation.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch (c70592) in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the limited information provided, a thorough medical assessment could not be performed.The reported damage could be confirmed upon visual inspection.The device is observed to be bent at the opening and shows signs of intensive wear.The deformation on the device does indicate that high force was applied and that the device might have been used for final impaction of the cup.The surgical technique (lit.No.01620-en (1582) v7 10/20) does clearly state that the introducer instrument is not meant for final impaction.However, based on available information it cannot clearly be determined if miss-use of the device contributed to the reported damage.Smith and nephew does recommend to never use an instrument other than described in the corresponding surgical technique.Furthermore, 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.Based on the conducted investigation there is no indication that the device failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.The root cause cannot conclusively be determined.Nevertheless, smith and nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11684523
• Report Number: 9613369-2021-00158
• Device Sequence Number: 19606802
• Product Code: LXH
• UDI-Device Identifier: 07611996116632
• UDI-Public: 07611996116632
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75000649
• Device Catalogue Number: 75000649
• Device Lot Number: C70592
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/19/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention