MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP HEAD/LINER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75017089
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a thr the procedure the polarcup head/liner inserter (75017089 ) did not function properly.The device use in treatment was partially returned for investigation.Only the linear guide and the cache of the polarcup head-liner inserter were returned.The reported functional issue could therefore not be confirmed.However, a visual inspection observed the notch on the cache to be fractured and with heavy deformations indicating improper use of the device.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Normal wear and tear through repeated impaction as well as miss-use of the device are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Based on the conducted investigation the root cause is attributed to a component failure without any design or manufacturing related issues.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.
Event or Problem Description
It was reported that during a thr the procedure thepolarcup head/liner inserter did not function properly.The device was discovered to be fractured.No harm to patient or staff.No supplemental patient information is currently available.No substantial procedural delay because a functioning, smith & nephew back up was available and used to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: POLARCUP HEAD/LINER INSERTER
• 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: 11971339
• Report Number: 9613369-2021-00278
• Device Sequence Number: 19120950
• Product Code: LXH
• UDI-Device Identifier: 07611996103151
• UDI-Public: 07611996103151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75017089
• Device Catalogue Number: 75017089
• Device Lot Number: C62498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1