MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75004650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the polarstem inserter did not longer engage to screw down.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, impact marks are visible on the superior surface of the knob.Furthermore, the transversal pin of the knob is broken and finally, deformation of the plastic part of the handle around the transversal pin holes are visible, which indicate the application of high axial forces on the instrument via the knob.The batch record review revealed no deviation from the standard manufacturing processes that may have caused the reported issue.A complaint history review detected no additional complaint for the batch in question.The visible damage confirms that the instrument was improperly used to impact a stem.It has to be noted that the stem inserter is intended to be used for the insertion of cemented stems, while the stem impactor (75023369) is to be used for impaction of uncemented stems.The stem inserter is not designed to withstand hammering impacts.Based on the performed investigation, the root cause of the reported event is attributed to an off-label use.The relevant surgical technique, 01217-en_v5 09/17, illustrates in details, how uncemented stems are implanted and which instrument should be used.No further actions will be initiated as a result of the present investigation.S+n will continue to monitor this device for similar issues."the returned component will be.".
Event or Problem Description
It was reported that during post surgery inspection for a thr procedure, the polarstem stem inserter did not longer engage to screw down.The material of the product is twisted / bent.Here was no a delay, a s&n back up was available if needed.The patient outcome is fine.Investigation determined that the device is fractured.

• Brand Name: POLARSTEM STEM INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11692484
• Report Number: 9613369-2021-00160
• Device Sequence Number: 11844925
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 75004650
• Device Catalogue Number: 75004650
• Device Lot Number: D57923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1