MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL LATARJET CANN. SCREWDRIVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	285220
Medical Device Problem Code	Material Deformation (2976)
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
Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the distal driver end of the device was slightly bent.Also, it was evident that the driver end was stripped as the driver was heavily worn.The device is reusable, and was manufactured 8 years ago.It is possible that the device was reused multiple times which would cause wear on the driver end therefore is a potential root cause for the reported failure.However, we cannot discern a definitive root cause for the reported failure.At this point, 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
During latarjet procedure, when surgeon tried to place screw driver over guide wire the tip would not fit.The tip was bent so the driver would not slide over k wire.There is no patient consequence.This is report 1 for 1 (b)(4).

• Brand Name: LATARJET CANN. SCREWDRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9069958
• Report Number: 1221934-2019-58335
• Device Sequence Number: 14072734
• Product Code: LXH
• UDI-Device Identifier: 10886705017904
• UDI-Public: 10886705017904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 285220
• Device Lot Number: 10F2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1