MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; SCREWDRIVER

Model Number	71175056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference number: case (b)(4).
Event or Problem Description
It was reported that, during a procedure the evos sm 2.5mm fixed handle linear hex dr broke off into the evos 2.5mm locking drill guide.It is unknown how the procedure was finished, however; there was no surgical delay reported.No further complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation a visual inspection of the returned evos sm 2.5mm fixed handle linear hex dr confirms the device is broken on the end.The broken piece was not returned with the device.The device also shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 instrument 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, during a procedure the evos sm 2.5mm fixed handle linear hex dr broke off into the evos 2.5mm locking drill guide.The two point to point rdce frcps w/ pts brd are bent.All pieces were retrieved from the patient.Procedure was finished with a s&n back up device, without surgical delay reported.No further complications were reported.

• Brand Name: EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12752714
• Report Number: 1020279-2021-07843
• Device Sequence Number: 20027450
• Product Code: HXX
• UDI-Device Identifier: 00885556636558
• UDI-Public: 00885556636558
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71175056
• Device Catalogue Number: 71175072
• Device Lot Number: 17MUP0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71175056/EVOS 2.5MM LOCKING DRILL GUIDE; 71175072/EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; EVOS 2.5MM LOCKING DRILL GUIDE; EVOS 2.5MM LOCKING DRILL GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown