MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM BALL HEAD IMPACTOR

Model Number	75023710
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the polarstem ball head impactor broke.No pieces fell into patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed, or further consequences were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, the polarstem ball head impactor and polarstem modular head for 21000662 broke.No pieces fell into patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed, or further consequences were reported.The device in scope of this complaint, was not returned for investigation.A review of the complaint history was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.A review of the risk management documentation verified the failure mode and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.There are no indications that the complaint device did not meet manufacturing specifications upon release for distribution.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.Should additional information become available, this complaint will be reopened.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, the polarstem ball head impactor and polarstem modular head for 21000662 broke.No pieces fell into patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed, or further consequences were reported.The device in scope of this complaint, was returned for investigation.The reported failure mode was confirmed upon visual inspection.A review of the complaint history was performed and no further complaints were found for the affected lot number.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the risk management documentation verified the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.Based on the performed investigations, the reported failure mode could be confirmed.A relationship between the reported event and the device can be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.Normal wear and tear through repeated use is known to contribute 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.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This investigation is considered closed.The complaint device will be discarded.
Event or Problem Description
It was reported that, during a thr surgery, the polarstem ball head impactor tip is deformed.No pieces fell into patient.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed, or further consequences were reported.

• Brand Name: POLARSTEM BALL HEAD IMPACTOR
• Common Device Name: IMPACTOR
• 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: 13543317
• Report Number: 9613369-2022-00033
• Device Sequence Number: 4162284
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 06/16/2022

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 Model Number: 75023710
• Device Catalogue Number: 75023710
• Device Lot Number: A52192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 03/28/2022; 06/13/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/28/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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