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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a bhr surgery, the head of a bhr square headed nail broke off while being removed with a slam hammer, and pieces felt into the patient.Pieces were removed using a jacobs chuck on a drill and a smith and nephew nail was used as a back up device for completing the procedure.A minor delay was reported due to this event.No patient injury was reported.
Additional Manufacturer Narrative
G3, h2, h3, and h6: a bhr square headed nail was received for inspection.The instrument was intended for use in treatment.A visual inspection was performed.It was observed that small marks and scratches were present across the whole length of both instruments.The tip of the nail did not appear to be blunt/dull.Batch numbers of the instruments were faded and non legible.The nail head had broken away on both instruments inspected.A functional evaluation was not needed as the failure had 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.The labelling of the instrument was found to be correct with no issues noted.A risk management review was performed.The risk was identified within the risk file.Due to the fact that the nails have not been manufactured in the correct way, the risk documented risk assessment for the nail does not apply.Another risk assessment was performed and a high risk was identified, due to the frequent occurrence of instrument failure.No additional risks were identified as result of the reported event.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 unauthorized drawing change by the supplier.The instrument cannot be fixed and will be retained at aurora.D10: add concomitants g2: report source update h6: update codes d8 and d9: device returned.
Additional Manufacturer Narrative
Additional information has been included into this report in h7 and h9.
Additional Manufacturer Narrative
H3, h6, h7, h9: a bhr square headed nail was received for inspection.The instrument was intended for use in treatment.A visual inspection was performed.It was observed that small marks and scratches were present across the whole length of both instruments.The tip of the nail did not appear to be blunt/dull.Batch numbers of the instruments were faded and non legible.The nail head had broken away on both instruments inspected.A functional evaluation was not needed as the failure had 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.The labelling of the instrument was found to be correct with no issues noted.A risk management review was performed.The risk was identified within the risk file.Due to the fact that the nails have not been manufactured in the correct way, the risk documented risk assessment for the nail does not apply.Another risk assessment was performed and a high risk was identified, due to the frequent occurrence of instrument failure.No additional risks were identified as result of the reported event.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 unauthorized drawing change by the supplier.The instrument cannot be fixed and will be retained at (b)(6).

• 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: 11838191
• Report Number: 3005975929-2021-00252
• Device Sequence Number: 1085587
• Product Code: NXT
• UDI-Device Identifier: 03596010504630
• UDI-Public: 03596010504630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 999908
• Device Catalogue Number: 999908
• Device Lot Number: 20LW15963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 11/02/2021; 09/15/2022
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 11/08/2021; 09/12/2022; 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown