MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS LARGE TGTR 3.5MM LINEAR HEX DRVR QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71177733
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation an evos large tgtr 3.5mm linear hex drvr qc broke off in a large screwdriver handle while tightening a screw.The procedure was resumed, without any delay, using a s+n back-up device.It is unknown if pieces fell into the patient, but no injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an internal fixation an evos large tgtr 3.5mm linear hex drvr qc broke off in the handle while tightening a screw.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H10: additional information added in b5.H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the evos hex driver.The device was not returned for evaluation; therefore, a device analysis could not be performed.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A review of complaint history revealed similar events for the listed device over the previous 12 months.The batch number provided is not valid within the system, even though the review was performed and did not reveal similar events.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS LARGE TGTR 3.5MM LINEAR HEX DRVR QC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18428777
• Report Number: 1020279-2024-00005
• Device Sequence Number: 7772101
• Product Code: LXH
• UDI-Device Identifier: 00885556767719
• UDI-Public: 885556767719
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 71177733
• Device Lot Number: 2797
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LRG SCRWDRVR HNDL(PN:71173547,LN:22BTMH490)
• Patient Sex: Unknown