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	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bhr dysplasia drill 3.2mm was broken in transit.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: a bhr dysplasia drill (part 90127619, lot s1404013) was returned for investigation after being reported as broken in transit.There was no patient involvement.A visual inspection was performed.Marks and scratches were noted across the length of the instrument, consistent with surgical use.The end of the drill has broken off.This confirms the reported complaint.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 instrument involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Based on the investigation a root cause could not be established for the instrument break.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 cannot be repaired and will be retained at smith+nephew.

• 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: 11708197
• Report Number: 3005975929-2021-00188
• Device Sequence Number: 3437230
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: S1404013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1