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

Model Number	75023710
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after procedure, was noticed that the black bumper tip that connects to the polarstem ball head impactor on was found too stiff to remove on two devices after use for cleaning (b)(4).There was no patient involved since the event was noticed after procedure.Two polarstem modular head for 21000662 (b)(4) were received, it is unknown what type of failure do these devices have.
Additional Manufacturer Narrative
H3, h6: it was reported that after procedure the tip that connects to the polarstem head impactor was found too stiff to remove after use for cleaning.The reported impactor handle (75023710) and the modular head (75023711) , used in treatment, were returned for investigation.It can be confirmed that the parts cannot be disassembled using the usual amount of force.However, the parts could be separated by hand.The impactor handle was heavily deformed and showed scratches which might originate from the use of pliers.The modular head does not show significant signs of use.Therefore, the relationship between devices and the reported event can be confirmed.The production documentation was reviewed.There were no indications found, that the part failed to match specification at the time of manufacturing.For the batches in scope, no further complaints with the same failure mode were reported.The parts were stuck together, most likely because the impactor handle was deformed at the connection site.It must be noted that pliers should never be used to work on the instrument.Therefore, the root cause is attributed to an off-label use.Regarding the modular head, no problems could be found.This complaint was reopened as the parts were returned for investigation.Smith and nephew will monitor this complaint for further similar issues.The returned devices will be discarded.

• 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: 11838434
• Report Number: 9613369-2021-00225
• Device Sequence Number: 19944341
• Product Code: HWA
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/15/2021

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
• Device Lot Number: B65264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1