MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR SQUARE HEADED NAIL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	999908
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a bhr square headed nail was bent.It is unknown whether the event happened during surgery and if there was patient involvement.
Additional Manufacturer Narrative
H3, h6: a bhr square headed nail (part 999908, lot stk1309) was received for investigation after being reported as bent.A visual inspection was performed.Scratches were observed across the instrument, consistent with surgical use.Laser marking on the nail is very faded.The nail has a bend in the middle, 81.57mm from the tip of the nail.This confirms the reported complaint.A review of the complaint history for the bhr square headed nail was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.The documents related to the complained part cannot be reviewed due to the age of the instrument (13+ years).However, all the parts would have been subjected to 100% inspection at the time of release.The bend reported would not have been a manufacturing issue.Based on the available information, the root cause of the reported issue is an end of life problem.No preventative or corrective action has been initiated as a result of this investigation.The returned instrument part cannot be repaired and will be retained.

• Brand Name: BHR SQUARE HEADED NAIL
• 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: 11468424
• Report Number: 3005975929-2021-00144
• Device Sequence Number: 17074969
• Product Code: NXT
• UDI-Device Identifier: 03596010504630
• UDI-Public: 03596010504630
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 999908
• Device Catalogue Number: 999908
• Device Lot Number: STK1309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1