MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MOD TRIAL NECK 0; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	90035582
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the mod trial neck 0 was cracked.As this was noticed upon field inspection, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that during a routine field inspection the mod trial neck 0 was cracked.There was no patient involvement.A modular trial neck (part no.90035582, batch no.S0803084) intended for use in treatment was returned for investigation.A review of the historical complaints data for the modular trial neck was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch and for the part number and the reported failure mode.Due to the age of the instrument, there is no traceability within sap and the manufacturing records for this device cannot be reviewed.However, the released devices would have met manufacturing specifications at the time of production.Modular trial necks have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A visual inspection was performed.Marks, scratches, and dents were visible across the whole device, consistent with years of surgical use.A large crack is visible, a portion of material is missing.This confirms the reported complaint.Laser markings are present, correct and legible, yet slightly faded.A functional evaluation was not performed as the instrument was confirmed to be broken/non-functional during visual inspection.Based on the limited information provided and product evaluation of the returned instrument, we cannot advance the investigation our investigation remains inconclusive, and a definitive root cause cannot be determined.Considering the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.The device cannot be repaired and will be retained.

• Brand Name: MOD TRIAL NECK 0
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13113095
• Report Number: 3005975929-2021-00593
• Device Sequence Number: 3295752
• Product Code: LXH
• UDI-Device Identifier: 03596010606235
• UDI-Public: 3596010606235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/07/2022

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 Catalogue Number: 90035582
• Device Lot Number: S0803084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/06/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/07/2022
• 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