MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 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)
Type of Reportable Event	Serious Injury
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) incomplete.The lot number is currently unavailable.
Event or Problem Description
The wick broke durin procedure.(ancillary n°12).Procedure has been extended for an hour.No patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary; the complaint device was received and evaluated.Visual inspection revealed that the distal portion of the drill was broken, confirming this complaint.Closer visual inspection revealed a break at the laser weld which connects the drill tip to the shaft, which caused the entire drill tip including the portion contained within the shaft to become completely disengaged.A k-wire was returned within the device.The distal end of the k-wire was bent and stuck within the drill tip.The bent wire indicates that the drilling was likely off axis, which could cause the weld to fail.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed one similar and one dissimilar complaint for this lot of devices released to distribution.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).

• Brand Name: LATARJET, GLENOID DRILL
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• MDR Report Key: 7139339
• Report Number: 1221934-2017-50088
• Device Sequence Number: 19119043
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 288241
• Device Lot Number: 16E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other