MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM MODULAR HEAD FOR 21000662; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75023711
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a thr surgery, the black tip of one (1) polarstem modular head for 21000662 chipped off and broke while being impacted.It is unknown how the procedure was completed or if there was any surgical delay.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H11: h2: updated information in d4 and h4.
Additional Manufacturer Narrative
H3, h6: the complaint device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that a distal fragment has broken-off.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed 15 additional similar complaints reported for the same batch, and 62 additional similar complaints for the same product number over the past 12 months with similar a failure mode.Review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from repeated resterilization, prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.Furthermore, the damage found in the visual inspection indicates that the device will not function as intended.Therefore, all reusable instruments must be routinely inspected for signs of wear and damage after reprocessing.Any instruments found to be damaged should be replaced as necessary to ensure their proper functioning and to maintain patient safety.This guidance is provided by smith & nephew orthopaedics ag (reference: lit.N°03389-en 1363 v4 01/25).The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARSTEM MODULAR HEAD FOR 21000662
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21932401
• Report Number: 9613369-2025-00086
• Device Sequence Number: 12988548
• Product Code: LXH
• UDI-Device Identifier: 07611996114393
• UDI-Public: 7611996114393
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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 Catalogue Number: 75023711
• Device Lot Number: D71761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 05/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/20/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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