MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL LATARJET, GLENOID DRILL; CANNULATED SURGICAL DRILL

Catalog Number	288241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is not currently available.
Event or Problem Description
Sales rep reports a broken drill during a surgery.The break happened at the junction between the handle and the thread.Use of another instrument to finish the surgery with success.No patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is not being returned.The device is not available for physical evaluation and hence this complaint cannot be confirmed.Furthermore, no lot numbers were supplied which precludes conducting a device history record review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.We cannot discern a root cause for the reported failure mode.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.Udi: (b)(4)-incomplete.Depuy synthes has been informed that the lot number is not available.

• Brand Name: LATARJET, GLENOID DRILL
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7374874
• Report Number: 1221934-2018-50358
• Device Sequence Number: 1393487
• Product Code: HTW
• UDI-Device Identifier: 10886705027316
• UDI-Public: 10886705027316
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 288241
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1