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

Model Number	75023710
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a polarstem ball head impactor is jammed.The procedure was completed without delay using a s+n back-up device.As this was noticed after surgery, the patient was no longer involved.
Additional Manufacturer Narrative
H3, h6: it was reported that a modular head for impactor (75023711) and the handle (75023710) cannot be separated.The two devices used in treatment were no returned for investigation.Therefore, the relationship between the reported event and the device cannot be confirmed.The batch number of the two devices not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.As no device was received for investigation, a visual inspection could not be performed.The root cause stays undetermined after investigation.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.

• 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
• MDR Report Key: 11862440
• Report Number: 9613369-2021-00259
• Device Sequence Number: 3172544
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1