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

Model Number 90128257

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a thr surgery, a bhr curved cup introducer was found to be broken.No surgical delay reported, as a smith and nephew back up device was available.No patient harm reported.

Manufacturer Narrative

H3, h6: a bhr curved cup introducer (part no.90128257, batch no.1019235898) was returned for investigation.It was reported that after a total hip arthroplasty surgery, the instrument used in treatment was found to be broken.No surgical delay reported, and no patient harm reported.A review of the complaint history for the bhr curved cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for bhr curved cup introducer.The relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.Since the device is broken, a functional evaluation was not performed; the failure mode of the device can be visually examined.A visual inspection was performed.Marks and scratches are visible across the whole length of the device consistent with surgical use.The strike cap is visibly worn, consistent with impact damage and the wire grip assembly is broken.This confirms the reported complaint.Based on the available information and the product evaluation, a definitive root cause cannot be determined, and our investigation remains inconclusive.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.No further investigation is warranted for this complaint.If additional information is received, this case 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: BHR CURVED CUP INTRODUCER
• Type of Device: 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: 12484773
• MDR Text Key: 271803309
• Report Number: 3005975929-2021-00408
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: 1019235898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1