MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD OFFSET CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	90128275
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a thr, the threaded rod in one (1) offset cup introducer broke during impaction of the bhr shell.No pieces were noticed by the surgeon in the wound.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
An offset cup introducer, for use in treatment, was returned for evaluation.It was reported that the threaded rod broke during impaction of bhr shell.The procedure was resumed, without any delay, using a smith+nephew back-up device.A visual inspection of the returned device reveals several components from the chain assembly broke off.These pieces were not returned.Functional evaluation not performed as failure confirmed through visual inspection.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified.This will continue to be monitored via routine trending.The production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations was performed.Following the review, no prior applicable escalation actions were identified.Based on the information provided our investigation remains inconclusive and a definitive root cause cannot be determined.Factors known to contribute to the alleged fault include excessive use or force, making the instrument susceptible to breakage.It should be noted that the bhr surgical technique states ¿examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage.¿ the device will be retained.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: OFFSET CUP INTRODUCER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 18075632
• Report Number: 3005975929-2023-00156
• Device Sequence Number: 20749531
• Product Code: NXT
• UDI-Device Identifier: 03596010591531
• UDI-Public: 03596010591531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 90128275
• Device Lot Number: 4672567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown