MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BRISTOW-LATARJET GLENOID 2.9 MM DRILL BIT; NON-STERILE FLUTED SURGICAL DRILL, REUSABLE

Catalog Number	285143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Udi: (b)(4).Lot number is unavailable.
Event or Problem Description
It was reported via phone by the sales rep that during a latarjet shoulder procedure, the customer's latarjet glenoid drill bit broke in the patient's bone.The fragment was removed.The patient had hard bone, and this caused a 30 minute delay.The device was discarded by the customer.
Additional Manufacturer Narrative
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.If additional information should become available, a supplemental medwatch will be submitted accordingly.The lot number was reported as unknown in the initial report and has been updated as 13d02; therefore, udi: (b)(4).The complaint device was received and inspected.The complaint can be confirmed.It was observed that the drill was heavily deformed.The drill end was detached from the shaft of the device at the brazing point.It was reported that the patient's bone density was hard.It is possible that the patient's anatomical factors caused the drill to break when the surgeon applied force to it while drilling.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.

• Brand Name: BRISTOW-LATARJET GLENOID 2.9 MM DRILL BIT
• Common Device Name: NON-STERILE FLUTED SURGICAL DRILL, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7805605
• Report Number: 1221934-2018-54524
• Device Sequence Number: 1510688
• Product Code: HTW
• UDI-Device Identifier: 10886705022533
• UDI-Public: 10886705022533
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/25/2018

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: 285143
• Device Lot Number: 13D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/09/2018
• Patient Sequence Number: 1