MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR TRIAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	90051050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the sterilization process for a thr, a bhr trial head 50mm was observed to be broken.Surgery was performed, without any delay, with a smith & nephew backup device instead.Since incident occurred before surgery, patient was not yet involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: a bhr trial head 50mm (part: 90051050, lot: s0803301) was returned for evaluation.It was reported that, during the sterilization process, the instrument was observed to be broken.Surgery was performed, without any delay, with a smith & nephew backup device instead.Since the incident occurred before surgery, patient was not yet involved.The instrument is for use in treatment.A visual inspection of the instrument was performed.There are marks and scratches across the trial head.Part of the plastic has chipped off from around the edge of the window.A functional evaluation was not performed as the reported failure was confirmed through visual inspection.A review of the historical complaints data for the bhr trial head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other complaints were identified to involve this batch.No other similar complaints were identified for the part number and the reported/related failure mode.However, as the device is no longer sold, no action is to be taken.Manufacturing records cannot be reviewed as the manufacturer of the instruments, symmetry, no longer exists.However, all instruments 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 review of historical quality escalations related to the product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.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.¿ it is unknown how many cycles the device has gone through in its 12+ years in use.Based on the evaluation of the returned instrument we can confirm the reported complaint.A probable root cause for the failure, in light of the age of the instrument, is that the device has reached the end of its useful life.Based on this investigation, the need for corrective and preventative actions is not indicated.The device cannot be repaired and will be retained.Corrected data: h3.

• Brand Name: BHR TRIAL HEAD 50MM
• 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: 15358647
• Report Number: 3005975929-2022-00466
• Device Sequence Number: 19231533
• Product Code: NXT
• UDI-Device Identifier: 03596010550385
• UDI-Public: 03596010550385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 90051050
• Device Catalogue Number: 90051050
• Device Lot Number: S0803301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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