MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA DRILL 3.2MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90127619

Device Problem Break (1069)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the bhr dysplasia drill 3.2mm was broken.It is unknown if this was noticed during surgery or not; therefore, patient involvement has not been confirmed.

Manufacturer Narrative

H3, h6: a bhr dysplasia drill 3.2mm (part number 90127619, batch number s0803331) has been received for investigation.The instrument is for use in treatment.A visual inspection was performed.Marks and small scratches are visible across the length of the device, consistent with years of surgical use.Cutting edges show signs of wear and are visibly rolled.The end of the drill has broken off and cannot function.This confirms the reported complaint.Laser markings are present, correct, and legible, yet considerably faded.A functional evaluation was not performed as the instrument was confirmed to be broken/non-functional during visual inspection.A review of the complaint history for the bhr dysplasia drill 3.2mm 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 similar complaints were identified to involve this batch and for the part number and the reported failure mode, and this failure will continue to be monitored.Due to the age of the instrument, the document history for this instrument is not available.Therefore, the document history review for this device cannot be performed.However, the released instrument involved would have met manufacturing specifications at the time of production.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Based on the limited information provided and product evaluation of the returned instrument, we cannot advance the investigation, our investigation remains inconclusive, and a definitive root cause cannot be determined.Other factors which are known to contribute to the alleged fault are excessive force, misuse, general wear and tear.Should additional information be received, the complaint will be reopened.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 DYSPLASIA DRILL 3.2MM
• 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: 13078907
• MDR Text Key: 283839489
• Report Number: 3005975929-2021-00575
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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: 90127619
• Device Catalogue Number: 90127619
• Device Lot Number: S0803331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/20/2022
• 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: A
• Patient Sequence Number: 1