MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEAD CENTRE JIG - 11S; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	90128255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection or set up for thr, the head centre jig - 11s was found to be broken.As this was noticed before the surgery, no surgical delay was reported, and a smith and nephew back-up device was available to finished the procedure.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during set up or inspection for a total hip replacement surgery, a head centre jig was observed to be broken.No surgical delay was reported, and a smith and nephew back-up device was available to finish the procedure.No patient injury or other complications were reported.A head centre jig (part no.90128255, batch no.Unknown) which was used in treatment was returned for investigation.Without a definitive batch number, a complete complaint history review cannot be performed.A review of the historical complaints data for the head centre jig was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.However, the released devices would have met manufacturing specifications at the time of production.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Upon visual inspection it was noticed that the instrument was found to have general wear and tear, with scratches across the surface of the device.The laser marking was very faded, barely legible and cannot be confirmed.Based on the limited information provided and product evaluation of the returned instrument, we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Considering the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.The device cannot be repaired and will be retained.

• Brand Name: HEAD CENTRE JIG - 11S
• 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: 12103604
• Report Number: 3005975929-2021-00341
• Device Sequence Number: 4816272
• Product Code: NXT
• UDI-Device Identifier: 03596010542175
• UDI-Public: 03596010542175
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2022

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: 90128255
• Device Catalogue Number: 90128255
• Device Lot Number: 303550001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown