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 03/29/2021

Event Type  malfunction  

Event Description

It was reported that a bhr dysplasia drill 3.2mm was broken in transit.No case reported; therefore, there was no patient involvement.

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
• 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
• MDR Report Key: 11708197
• MDR Text Key: 246744490
• Report Number: 3005975929-2021-00188
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533562
• UDI-Public: 03596010533562
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1