MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET TOP HAT SCREW DRIVER; SURGICAL SCREWDRIVER, REUSABLE

Model Number	285295
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Itek employee.Without a lot number the device history records review could not be completed.Product was not returned.Investigation summary: the complaint device is not being returned.It was discarded by the customer therefore not available for a physical evaluation.It was reported that the device was dropped, so this is the root cause of this failure.This complaint cannot be confirmed.At this point in 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 as a means of monitoring the extent with 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 via phone that following a latarjet procedure the sales rep's top hat screwdriver was dropped and the tip of the device bent.The case was completed with this device with no patient harm or delay.The sales rep could not provide a lot number.The availability of the device is unknown.

• Brand Name: LATARJET TOP HAT SCREW DRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9125653
• Report Number: 1221934-2019-58616
• Device Sequence Number: 19482244
• Product Code: LXH
• UDI-Device Identifier: 10886705018086
• UDI-Public: (01)10886705018086(
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/13/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 285295
• Device Catalogue Number: 285295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1