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	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the birmingham hip dysplasia drill 3.2mm broke while drilling while inside the patient.No delay reported.No additional patient injuries reported.An s&n backup was available.
Additional Manufacturer Narrative
A bhr curved dysplasia drill 3.2mm (part number 90127619, batch number 6081100001) has been received for investigation.It was reported that the instrument broke while drilling inside the patient.No delay reported.No additional patient injuries reported.A review of the complaint history for the bhr dysplasia drill 3.2mm was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the dysplasia drill 3.2mm.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device 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.No further actions are required at this time.Visual inspection was performed on the instrument.Scratches could be seen across the instrument consistent with surgical use.Visual inspection confirms that the device has snapped into two pieces and cannot function, this confirms the reported complaint.A functional evaluation of the instrument was not performed as it was broken.Bhr surgical technique 04727 v2 45670103 revc 01/18 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".The root cause of the reported issue could not be determined conclusively.A potential root cause is general wear and tear which would not have existed on the instrument when originally produced and inspected by smith & nephew.The returned instrument part cannot be repaired and will be retained.

• 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: 11282865
• Report Number: 3005975929-2021-00080
• Device Sequence Number: 19926488
• Product Code: NXT
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90127619
• Device Catalogue Number: 90127619
• Device Lot Number: 6081100001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention