MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN COMP SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference number: (b)(4).
Event or Problem Description
It was reported that while hand tightening the compression screw, the tip of the compression screw driver broke off in the compression screw while doing a meta-tan surgery.This happened during final tightening.It was able to retrieve the broken off hex head from the inserted compression screw.This failure caused no adverse action or time delay with case.There was a smith and nephew back up device available.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned screw driver confirms the tip of the device is broken off.The broken piece was not returned with the device.This device was manufactured in 2015.This device exhibits signs of significant wear and usage.A medical investigation was conducted and confirms it has been communicated via e-mail, no relevant supporting clinical information will be provided, therefore, without the requested clinical information the root cause of the reported failure could not be determined.Per the report, it was reported the broken tip of the compression screwdriver was easily removed off the hex head from the inserted compression screw.According to the report, a smith and nephew device was used to complete the procedure.Since the reported failure did not cause any harm to the patient or delay in the procedure, no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management file revealed this failure mode was previously identified.This device is a reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that while hand tightening the compression screw, the tip of the compression screw driver broke off in the compression screw while doing a meta-tan surgery.This happened during final tightening.It was able to retrieve the broken off hex head from the inserted compression screw.This failure caused no adverse action or time delay with case.There was a smith and nephew back up device available.

• Brand Name: META-TAN COMP SCREW DRIVER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11407499
• Report Number: 1020279-2021-01775
• Device Sequence Number: 19975568
• Product Code: HSB
• UDI-Device Identifier: 00885556158333
• UDI-Public: 00885556158333
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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): 03/25/2021

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: 71631444
• Device Catalogue Number: 71631444
• Device Lot Number: 15FSY0044
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/07/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention