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

Model Number	90127619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up for a thr surgery the device tip was found chipped.There was no delay nor injury reported.A s&n backup device was available during surgery.
Additional Manufacturer Narrative
A bhr dysplasia drill was received for inspection (part number 90127619, batch 01105838).It was reported that during set up for a thr surgery the device tip was found chipped.There was no delay nor injury reported.A s&n backup device was available during surgery.A review of the complaint history for the bhr dysplasia drill was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.The production records were reviewed for the devices reportedly involved in this incident.The released instrument involved met manufacturing specifications at the time of production.Visual inspection was carried out on the instrument.It was noted that the drill has snapped.The majority of the drill is missing and cannot function.A functional evaluation could not be performed as tip of part is broken.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".Based on the available information and returned instrument a probable cause of the snapped drill may be misuse due to excessive force.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The instrument will be retained at aurora.

• Brand Name: BHR DYSPLASIA DRILL 3.2MM
• 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
• MDR Report Key: 10982859
• Report Number: 3005975929-2020-00492
• Device Sequence Number: 4241536
• Product Code: NXT
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2021

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: 90127619
• Device Catalogue Number: 90127619
• Device Lot Number: 01105838
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1