MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL RT; PIN, FIXATION, THREADED

Model Number	71441137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirmed that the gii mi in slt 3 mo ti cu bl rt is damaged.The thumb screw broke off which causes it to not properly function.The device shows signs of significant wear and use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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, a gii mi in slt 3 mo ti cu bl rt was found during inspection to have a piece broken off, rendering it unusable.No case reported; therefore, there was no patient involvement.

• Brand Name: GII MI IN SLT 3 MO TI CU BL RT
• Common Device Name: PIN, FIXATION, THREADED
• 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: 12789625
• Report Number: 1020279-2021-08002
• Device Sequence Number: 14413049
• Product Code: JDW
• UDI-Device Identifier: 03596010484093
• UDI-Public: 03596010484093
• Combination Product (Y/N): N
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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 Model Number: 71441137
• Device Catalogue Number: 71441137
• Device Lot Number: 17LM02401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown