MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 22/43; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000651
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr surgery, the polarcup trial insert slotted 22/43 ball broke into pieces when inserting the polar cup.All the pieces were recovered.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.No further complications reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that the polarcup trial insert slotted 22/43 ball broke into pieces when inserting the polarcup.All the pieces were recovered.The trial insert, used in treatment, was received for investigation.The reported failure mode can be confirmed.The device is broken into two pieces.No piece is missing.The relationship between the reported event and the device can be confirmed.The production documents could be reviewed.There are no indications that the part failed to match specification at the time of manufacturing.A complaint history review was performed, there was no further complaint reported for the batch in scope.The complaint is in line with the current risk management of the device.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.Review of past corrective actions was performed.No further escalation is required.The reported failure mode can be confirmed and the root cause stays undetermined after investigation.Since the part was manufactured in 2011, repeated use and sterilization could have contributed to the reported issue.To date, further actions are not deemed necessary.Smith + nephew is monitoring the device for further similar issues.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 22/43
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13896887
• Report Number: 9613369-2022-00062
• Device Sequence Number: 19909226
• Product Code: LXH
• UDI-Device Identifier: 07611996116656
• UDI-Public: 07611996116656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 75000651
• Device Catalogue Number: 75000651
• Device Lot Number: A75403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown