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 12/20/2021

Event Type  malfunction  

Event Description

It was reported that, during a thr surgery, the bracket that holds the x-bar to the bhr curved cup introducer broke off while the instrument was manipulated outside the patient.No surgical delay was reported to occur as a consequence of this malfunction, and the procedure was concluded with the same device.No patient harm was reported to occur due to this incident.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: it was reported that, during a thr surgery, the bracket that holds the x-bar to the bhr curved cup introducer (part number: 90128257, lot: unknown) broke off while the instrument was manipulated outside the patient.No surgical delay was reported to occur as a consequence of this malfunction, and the procedure was concluded with the same device.No patient harm was reported to occur due to this incident.The device is for use in treatment.A review of the complaint history for the bhr curved cup introducer was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.A review of the complaint history was performed using the part number for the bhr curved cup introducer and the failure mode for the prior 12 months to the aware date.Similar complaints have been identified.This will continue to be monitored.Without definitive lot numbers a documentation history review cannot be performed for the instrument involved.However, the released instrument 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.

Manufacturer Narrative

H3, h6: it was reported that, during a thr surgery, the bracket that holds the x-bar to the bhr curved cup introducer (part number: 90128257, lot: unknown) broke off while the instrument was manipulated outside the patient.No surgical delay was reported to occur as a consequence of this malfunction, and the procedure was concluded with the same device.As of today, device return and additional information has been requested for this complaint but has not become available.No patient harm was reported to occur due to this incident.The device is for use in treatment.A review of the complaint history for the bhr curved cup introducer was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.A review of the complaint history was performed using the part number for the bhr curved cup introducer and the failure mode for the prior 12 months to the aware date.Similar complaints have been identified.This will continue to be monitored.Without definitive lot numbers a documentation history review cannot be performed for the instrument involved.However, the released instrument 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 device or further information we cannot further investigate or confirm the reported complaint.If the product or additional information becomes 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
• 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: 13177042
• MDR Text Key: 286055796
• Report Number: 3005975929-2022-00004
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/28/2022; 02/03/2022
• Supplement Dates FDA Received: 01/28/2022; 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• 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