MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MOD TRIAL NECK +4; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	90035583
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: 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, the bottom of one (1) mod trial neck +4 was chipped.The procedure was resumed, without any surgical delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: d4, h6 (type of investigation), h11 (roi).Corrected data: h6 (investigation findings and investigation conclusions).H3, h6: the complaint device was not returned for investigation.A visual evaluation was performed on images provided by the complainant, and it showed the device is chipped.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for the mod trial neck.This failure will continue to be monitored via routine trending.The subject instrument has been in distribution for more than 5 years, likely experiencing multiple uses and worn or damaged from repeated normal use, misuse, and cleaning practices.Surgical instruments are subject to normal wear and tear throughout their life and over time may no longer perform as intended.Therefore, a device history records review for this incident is considered unnecessary as no other evidence to suggest a manufacturing deficiency in this case, thus this is unlikely to be identified as a cause or contributing factor.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The root cause can likely be ascribed to problems traced to the device reaching the end of its useful life.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 the bhr surgical technique.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: MOD TRIAL NECK +4
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21920611
• Report Number: 3005975929-2025-00031
• Device Sequence Number: 18322937
• Product Code: LXH
• UDI-Device Identifier: 03596010606242
• UDI-Public: 3596010606242
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 90035583
• Device Lot Number: S0804171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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