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	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that, a 6.8mm guide bar bent.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: a guide bar 6.8mm (90127585) was returned for investigation.It was reported that, a guide bar is bent.There are some visible marks and scratches across the device, consistent with surgical use.There is a slight bend in the guide bar, laser marking is worn off and cannot be read.It confirms reported complaint.A review of the complaint history for the guide bar was performed using part number in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.Should the batch number become available at a later date then the dhr task will be re-opened and completed.Based on the available information, the proposed probable root cause for the failure is stress problem.Smith and nephew recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No preventative or corrective action has been initiated as a result of this investigation.The device cannot be repaired and will be retained.

• 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: 11526162
• Report Number: 3005975929-2021-00149
• Device Sequence Number: 11703201
• Product Code: NXT
• UDI-Device Identifier: 03596010590190
• UDI-Public: 03596010590190
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1