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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr was noticed the 6.8mm guide bar bent.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: a 6.8mm guide bar was returned for inspection.It was reported that, during a thr was noticed the guide bar was bent.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.Due to worn laser marking, the batch number is not visible.Therefore a manufacturing record and complaint history review could not be performed.Visual inspection was performed which noted that there are marks and scratches across the device, consistent with surgical use.The guide bar has a slight bend.Laser marking is completely worn and no longer visible.Functional evaluation was performed which noted that assembly is acceptable.This confirms the reported complaint.It should be noted that the bhr surgical technique 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".The probable root cause is unknown.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The instrument will be retained at aurora as it cannot be reworked or repaired.

• 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
• MDR Report Key: 11568136
• Report Number: 3005975929-2021-00157
• Device Sequence Number: 4206017
• Product Code: NXT
• UDI-Device Identifier: 03596010590190
• UDI-Public: 03596010590190
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 90127585
• Device Catalogue Number: 90127585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1