MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM K-WIRE LCK GD - 1 PC; PLATE, FIXATION, BONE

Model Number	71173491
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during the procedure that the surgeon was unable to screw into the implants, because the threads of devices were stripped.Although the procedure was completed without delay, the surgeon had to change the surgical technique to finished the surgery.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed and complaint could not be confirmed.The clinical investigation concluded that this case reports that the k-wire locking guide was unable to be screwed into the plates because the threads of device was stripped.Per email communication, the procedure was successfully completed after a change in surgical technique, using free-handed targeting.There was no patient injury or delay reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.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: 2.0MM K-WIRE LCK GD - 1 PC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10950764
• Report Number: 1020279-2020-06983
• Device Sequence Number: 3169926
• Product Code: HRS
• UDI-Device Identifier: 00885556016718
• UDI-Public: 00885556016718
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2021

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: 71173491
• Device Catalogue Number: 71173491
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 08/08/2021
• 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