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 Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, the head of a bhr square headed nail broke off and detached from the nail while being hammered out.No broken pieces felt into the patient and no backup device was needed to conclude the surgery.Neither surgical delay nor patient injury were reported.
Additional Manufacturer Narrative
A bhr square headed nail was received for inspection.The instrument was intended for use in treatment.A visual inspection was performed.Marks and scratches are present across the whole length of the instrument and are consistent with surgical use.The nail head has broken away.A functional evaluation was not needed as the failure has been confirmed through visual evaluation.Testing was also performed on 3 nails affected by the same issue (from semi finished batch 01129965).All 3 nails tested failed within 6 cycles.The acceptance criteria per the protocol was not met by any of the three tested nails.A review of the complaint history for the bhr square headed nail was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the square headed nail.The other 3 complaints relate to the head falling off the pin, this will continue to be monitored.Quality escalations were raised to stop any further distribution of the parts that may be affected, further quality investigations were raised to find the potential root cause and correct the issue to ensure that it does not happen again.A health hazard evaluation was performed to evaluate the potential risk that the issue may have to patients and health professionals which concluded that it was appropriate to initiate a field action for the affected parts.A product prints/specifications/procedure review was performed.It was discovered that parts were being manufactured to a different mahe drawing.This design calls for nail attachment to the block using a blind-hole and welding, which has resulted in the failure of the head becoming detached from the pin.The specification change was not communicated to smith and nephew.Based on the returned instrument and investigation a probable root cause for the head becoming detached from the pin is device design, caused by an unauthorised drawing change by the supplier.The instrument cannot be fixed and will be retained at aurora.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11846663
• Report Number: 3005975929-2021-00272
• Device Sequence Number: 3723921
• Product Code: NXT
• UDI-Device Identifier: 03596010504630
• UDI-Public: 03596010504630
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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: 20LWL5963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 08/06/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/11/2021; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2242-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown