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

Model Number	90129412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery inside the patient the device got broken, there was no delay nor injury reported.The surgery was finished using the same device, no backup device was required.
Additional Manufacturer Narrative
It was reported that during surgery inside the patient the device got broken, there was no delay nor injury reported.The surgery was finished using the same device, no backup device was required.As of today, the instrument, which was used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the head centre jig was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.It is unknown how many cycles the instrument has been through over it's lifespan.It should be noted that the bhr surgical technique 04727 v2 45670103 revc 01/18 states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".Smith and nephew has not received the adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
Additional Manufacturer Narrative
H3, h6: a head centre jig (90129412, 6095860001) was returned for investigation.It was reported that during surgery inside the patient the device got broken, there was no delay nor injury reported.The instrument was used in treatment.A review of the complaint history for the head centre jig was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.Visual inspection was carried out on the instrument, marks and scratches were noted across the instrument and consistent with surgical use.The screw on the jig has broken off, the jig can move without considerable force and will not lock into a set position.The jig and guide rod are not aligned when put together, this confirms the reported complaint.Functional evaluation of the device was not possible as the screw on the jig has broken off.It is unknown how many cycles the instrument has been through over it's lifespan.It should be noted that the bhr surgical technique 04727 v2 45670103 revc 01/18 states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".Smith and nephew has not received the adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The root cause of the reported issue could not be determined conclusively.A potential root cause is general wear and tear which would not have existed on the instrument when originally produced and inspected by smith & nephew.The returned instrument part 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10555726
• Report Number: 3005975929-2020-00343
• Device Sequence Number: 14343565
• Product Code: NXT
• UDI-Device Identifier: 03596010591463
• UDI-Public: 03596010591463
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 90129412
• Device Catalogue Number: 90129412
• Device Lot Number: 6095860001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 05/25/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/25/2020; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other