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

Model Number 90127736

Device Problem Fracture (1260)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

It was reported that, while setting up for a thr, a bhr debris cap 50mm was found to be broken.Surgery was performed, without delay, using a s+n backup device instead.Since incident occurred before procedure, patient was not yet involved.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: a bhr debris cap (part: 90127736, lot: s1104200) was returned for evaluation.It was reported that, while setting up for a thr, the instrument was found to be broken.Surgery was performed, without delay, using a s+n backup device instead.Since the incident occurred before the procedure, the patient was not yet involved.The instrument is for use in treatment.A visual inspection was performed on the returned device.Some of the plastic of the mating part has snapped off.The debris cap is slightly marked and discoloured consistent with surgical use.The laser markings are clear and legible.A functional evaluation was not performed as the reported failure was confirmed through visual inspection.A review of the historical complaints data for the debris cap 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.No other complaints were identified to involve this batch and no other similar complaints were identified for the part number and the reported/related failure mode.A review of historic quality escalations related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.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 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 instrument has been through in its 10+years of use, damage from repeated use can occur.Based on the evaluation of the returned instrument we can confirm the reported complaint.However a definitive root cause cannot be determined.A possible factor known to contribute to the reported failure is excessive force used during surgery.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 DEBRIS CAP 50MM
• 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: 15372302
• MDR Text Key: 300325314
• Report Number: 3005975929-2022-00468
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556074725
• UDI-Public: 00885556074725
• 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
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90127736
• Device Catalogue Number: 90127736
• Device Lot Number: S1104200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2022
• 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: Reuse
• Patient Sequence Number: 1