MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTI ROTATION BAR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71674041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, in a intertan case the anti rotation bar snapped while using the lag screw drill.Delay from (0-30) minutes reported.Backup device available.No injury or impact to patient reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned rotation bar confirms the device fractured into two pieces.Both pieces were returned for evaluation.The device was manufactured in 2017.This device exhibits signs of significant wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: ANTI ROTATION BAR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9390392
• Report Number: 1020279-2019-04187
• Device Sequence Number: 11296048
• Product Code: MDM
• UDI-Device Identifier: 03596010605238
• UDI-Public: 03596010605238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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 Catalogue Number: 71674041
• Device Lot Number: 17BSP0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1