MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 6.8MM GUIDE BAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	90127585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a thr, a 6.8mm guide bar dissembled during reaming.The shaft of the guide bar was stuck in the reamer, and the screw was recovered from the incision by hand.Procedure was completed with a backup device, no delay reported.Patient was not harmed beyond the problem reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery, a 6.8mm guide bar (part: 90127585, lot: unknown) dissembled during reaming.The shaft of the guide bar was stuck in the reamer, and the screw was recovered from the incision by hand.The procedure was completed with a backup device, no delay reported.The patient was not harmed beyond the problem reported.The device is for use in treatment.A review of the complaint history was performed using the part numbers for the guide bar in search of complaints involving the failure mode throughout the lifetime of the product.No other similar complaints have been identified for the device.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Without return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: 6.8MM GUIDE BAR
• 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: 12647131
• Report Number: 3005975929-2021-00475
• Device Sequence Number: 11129696
• Product Code: NXT
• UDI-Device Identifier: 03596010590190
• UDI-Public: 03596010590190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/21/2022

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: 90127585
• Device Catalogue Number: 90127585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown