MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK DEPLOYMENT GUN *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	214710
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number (b)(6).Investigation summary: according to the information provided, it was reported that the gun failed to fully tension the sutures on the anchor.The complaint gun was received and evaluated.Visual inspection revealed several marks on the gun suggesting that the device has been heavily used on the field and appearing in a worn condition.In addition, rusted areas were found on the trigger, possible related to the sterilization method.This device is required to be thoroughly cleaned to avoid friction during deployment.Functional testing was performed using a sample versalok anchor and no resistance was found and the lock function was successfully executed.Since the suture was not returned, it's no possible to evaluate if the suture condition could preclude the device to function as expected, therefore, the complaint cannot be confirmed.A definitive root cause for the user to have experienced this failure could not be confirmed at this moment.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email, that during a rotator cuff repair, a deployment gun failed to fully tension the sutures on anchor engagement, sutures had to be tensioned by hand to continue with procedure.No surgical delay or patient consequence reported.Additional information received from the affiliate reported a minute delay with no impact to the patient or user.The affiliate reported the suture had to tensioned by hand and the case was successfully completed.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9946411
• Report Number: 1221934-2020-01128
• Device Sequence Number: 17067938
• Product Code: LXH
• UDI-Device Identifier: 10886705004416
• UDI-Public: 10886705004416
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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: 214710
• Device Catalogue Number: 214710
• Device Lot Number: 1403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1