MAUDE Adverse Event Report: DEPUY MITEK LLC US 7X15 AND 8X15MM MODULAR DRIVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	219447
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: mitek employee.Without a lot number the device history records review could not be completed.Product was not returned.Investigation summary: the complaint device was discarded and is not available for physical evaluation.The reported complaint cannot be confirmed.The likely root cause of the reported failure is wear of the device over time; however, a specific root cause cannot be conclusively determined.The lot number of the device was unable to be provided which precludes a dhr review and a lot specific complaint history search.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.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.
Event or Problem Description
It was reported by the sales rep that his 5x12 and 6x12mm modular driver and 7x15 and 8x15mm modular driver were bent by the tips were bent and his tendon sizer 4-9mm had faded laser lines during a bicep procedure.The case was completed with other like devices.There were no patient consequences or delays.The devices were discarded by the customer.This is report 2 of 2 for (b)(4).

• Brand Name: 7X15 AND 8X15MM MODULAR DRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9010487
• Report Number: 1221934-2019-58279
• Device Sequence Number: 14007921
• Product Code: LXH
• UDI-Device Identifier: 10886705006533
• UDI-Public: 10886705006533
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2018

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: 219447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1