MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLASSIC INSERTION WRENCH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	110054
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an internal fixation procedure, when inserting the lag screw with the classic insertion wrench device, the tip of the device snapped loose.The procedure was resumed after a non-significant delay, using the same device.No pieces were left inside of the patient.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: case: (b)(4).
Additional Manufacturer Narrative
H10: additional information updated section d4 and d9.
Additional Manufacturer Narrative
Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that the device has a cracked and didn't break, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.The investigation findings are attached to comply with the quality standards.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip of the shaft sub-assembly has a large crack in it.The wrench stabilizer portion of the device was not returned.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 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.H6: medical device problem code.

• Brand Name: CLASSIC INSERTION WRENCH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 18357505
• Report Number: 1020279-2023-02514
• Device Sequence Number: 12410705
• Product Code: KTT
• UDI-Device Identifier: 03596010033499
• UDI-Public: 03596010033499
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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 Expiration Date: 09/20/2006
• Device Catalogue Number: 110054
• Device Lot Number: 60902142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 01/18/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2006
• 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
• Patient Sex: Unknown