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

Model Number	75023710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the polarstem ball head impactor tip was broken.As this was noticed in a non-surgical environment, there was not any patient involved.
Additional Manufacturer Narrative
H6: it was reported that, the polarstem ball head impactor tip was broken.As this was noticed in a non-surgical environment, there was not any patient involved.The device, intended for use in treatment, was returned for further investigation.Upon visual inspection, no irregularities were found regarding the reported part of the device in question.Upon functional testing, the tip in question was functioning properly.A complaint history review was performed.No other complaints regarding the batch in question could be detected.The production documentation was reviewed, no deviations from the standard manufacturing procedure were found.A 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 performed investigations, no problems were detected with the reported part of the device in question (the tip) and the 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/this complaint.Hence, a root cause analysis is not deemed necessary.The document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), states that all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Smith+nephew will continue to monitor for similar issues.The returned device will be scrapped.

• 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: 15241722
• Report Number: 9613369-2022-00470
• Device Sequence Number: 20025794
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: A55763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown