MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN ANTI ROTATION BAR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631434
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
the device, intended for use in treatment was returned for evaluation: a visual inspection was performed and confirmed the rotation bar has gouges/scratches on the tip.This device also show signs of excessive wear/usage.The manufactured date for this device is 2015.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.& nbsp; & nbsp; .
Event or Problem Description
It was reported that, the handle of a meta-tan anti rotation bar is out of alignment.Incident occurred during a meta tan nailing case with instruments outside the patient.The procedure was successfully completed using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H6: the device, intended for use in treatment was returned for evaluation: a visual inspection was performed and confirmed the rotation bar has gouges/scratches on the tip.This device also show signs of excessive wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship between the device and the reported incident was corroborated.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: META-TAN ANTI ROTATION BAR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11522611
• Report Number: 1020279-2021-02226
• Device Sequence Number: 19819833
• Product Code: HSB
• UDI-Device Identifier: 00885556158388
• UDI-Public: 00885556158388
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 71631434
• Device Catalogue Number: 71631434
• Device Lot Number: 15MSP0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1