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

Model Number	75004650
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
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 circular top of a polarstem stem inserter has detached from the rod that locks to the stem.Surgery was continued, after a delay of 30 minutes or less, with a sn back-up device.No harm to the patient or further complications reported.
Additional Manufacturer Narrative
Results of investigation: it was reported that, during a total hip replacement surgery, the circular top of a polarstem stem inserter has detached from the rod that locks to the stem.Surgery was continued with a back-up device.No harm to the patient or further complications reported.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.Therefore, the relationship between the reported event and the device can be confirmed.The batch record review revealed no deviation from the standard manufacturing processes that may have caused the reported issue.A complaint history review detected only two additional complaint for the batch in question with a similar reported failure mode.The complaint is in line with the current risk management file.Review of past corrective actions was performed.No further escalation is required.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 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 discarded.

• 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
• 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: 13403965
• Report Number: 9613369-2022-00018
• Device Sequence Number: 11995741
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 75004650
• Device Catalogue Number: 75004650
• Device Lot Number: D54778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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