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

Model Number	75000649
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr procedure the polarcup handle adapt.22mm trial insert bent and then broke inside of the patient.Surgery was delayed for less than 30 min.An s+n backup device was available and used.
Additional Manufacturer Narrative
Additional information in: d4, h4 and h6 (component code).Results of investigation: it was reported that during a thr procedure the polarcup handle adapt.22mm trial insert (75000649) bent and then broke inside of the patient.Surgery was delayed for less than 30 min.According to the complainant, no piece was left in the patient.The device used during treatment was returned for investigation.A review of the complaint history revealed one additional complaint reported for the batch in question.However, the device was manufactured in 2017 and a batch size of 100 pieces was produced.Furthermore a review of the batch record does not indicate that the device failed to match specification at the time of manufacturing.The reported failure mode is covered by the current risk management and risk analysis.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) v6.1 06/19) 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, all reusable devices shall be routinely inspected for wear and damage and replaced as necessary.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.Internal complaint reference (b)(4) corrected information in h6 (medical device problem code).

• 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: 10678861
• Report Number: 9613369-2020-00208
• Device Sequence Number: 3162188
• 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): 12/14/2020

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: 75000649
• Device Catalogue Number: 75000649
• Device Lot Number: B62043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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