MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP REDUCER PART FOR IMPACTOR

Model Number	75023344
Medical Device Problem Codes	Break (1069); Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a portion of the polarcup reducer part for impactor was chipped.As this was noticed upon field inspection, there was not patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: corrected information in d3 and g1 (manufacturing site name and address).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: it was reported that, a portion of the polarcup reducer part for impactor was chipped.As this was noticed upon field inspection, there was not patient involvement.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.So, the mentioned failure mode can not be confirmed.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The performed complaint history review for the complaint device revealed no previous complaints for the same batch.Review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for corrective action because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14819227
• Report Number: 1020279-2022-03109
• Device Sequence Number: 4613345
• Product Code: HWA
• UDI-Device Identifier: 07611996112337
• UDI-Public: 07611996112337
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2022

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 Expiration Date: 01/01/2024
• Device Model Number: 75023344
• Device Catalogue Number: 75023344
• Device Lot Number: C62731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 08/26/2022; 10/09/2022
• Initial Report FDA Received Date: 06/25/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/26/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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
• Patient Sex: Unknown