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

Catalog Number	288241
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(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).
Event or Problem Description
It was reported via phone by the sales rep that during a shoulder procedure, the customer's latarjet drill bit snapped off in the patient.The doctor removed the fragment with a grasper and used another drill bit to complete the procedure.There were no patient consequences, and the delay was less than 5 minutes.The device is being returned.The sales rep requested the older latarjet drill bit be sent to the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Investigation summary: the complaint device was received and evaluated.Visual inspection under magnification reveals no anomalies on the device.The weld between the drill tip and drill shaft broke leading to this failure.This complaint can be confirmed.A dhr review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one other similar complaint for this lot of devices that were released to distribution.Based on the complaint history and lot review, this failure seems to be an anomaly.A likely cause may have been exerting excess force or accidentally hitting bone during procedure.Other than this possibility, a root cause cannot be determined.At this point, 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.Udi: (b)(4).

• 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: 7390197
• Report Number: 1221934-2018-50356
• Device Sequence Number: 196104
• Product Code: HTW
• UDI-Device Identifier: 10886705027316
• UDI-Public: 10886705027316
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 17C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1