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

Model Number	90128257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the internal wire tensioner of a bhr curved cup introducer broke off upon impaction of the acetabular cup.No surgical delay was reported to occur due to this incident, and the procedure was concluded with a smith and nephew back up device.No patient harm was reported to occur as a consequence of this malfunction.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, the internal wire tensioner of a bhr curved cup introducer (part number: 90128257, lot number: s0801109) broke off upon impaction.No surgical delay was reported, and the procedure was concluded with a smith and nephew back up device.Both pieces remained connected to the impactor and were accounted for.No patient harm was reported.The instrument is for use in treatment.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.Similar complaints have been identified.This will continue to be monitored.As the supplier is no longer in business and there is no traceability within sap addition to the age of the instrument (>10 years old), the manufacturing records for the instrument cannot be reviewed.However, the released instrument involved would have 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.It should be noted that the bhr surgical technique (us) 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¿.Without return of the actual devices or further information we cannot further investigate or confirm the reported complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this particular case, our investigation remains inconclusive.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: BHR CURVED 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: 12561081
• Report Number: 3005975929-2021-00460
• Device Sequence Number: 11102915
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0801109
• 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: 09/17/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown