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	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr surgery the bhr curved cup introducer broke while being hit with mallet.The device broke while being used outside of the patient.The procedure was completed without delay and no harm to the patient was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery a bhr curved cup introducer (part number: 90128257, lot: s0607051) broke while being hit with mallet.The device broke while being used outside of the patient.The procedure was completed without delay and no harm to the patient was reported.The device is for use in treatment.A review of the complaint history for the bhr curved cup introducer was performed using part and 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.A review of the complaint history was also 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.As the supplier is no longer in business there is no traceability within sap for the instrument.Due to this reason and the age of the instrument (>10 years old), manufacturing records 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.A visual inspection was performed on the returned device.During the inspection marks and scratches were observed across the length of the device.A small amount of impact damage was seen on the head of the device.The wire grip assembly screw was seen to be completely snapped off into two separate parts.Laser markings on the device were slightly faded but fully legible and correct.This device is a reusable instrument that can be exposed to numerous surgeries, it is unknown how many cycles this instrument has been through in its 12+ years life; damage from repeated use can occur.Based on the available information and returned instrument we are able to confirm the reported complaint, the probable root cause is that the device reached the end of its useful life.If further information is received, then the complaint will be reopened and investigated.The instrument will be retained.Based on 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: 13252338
• Report Number: 3005975929-2022-00017
• Device Sequence Number: 11911777
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/10/2022

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 Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0607051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/10/2022
• 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