MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BRIST-LATRJET GLNOID 2.9DRBIT; NON-STERILE FLUTED SURGICAL DRILL, REUSABLE

Catalog Number 285143

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) incomplete.The lot number is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep in (b)(6) that during an arthroscopic latarjet surgical procedure while using a distal tibia allograft, the surgeon was using the 2.9mm glenoid cannulated drill bit and the drill bit broke inside the graft and glenoid of the patient.The surgeon was able to successfully retrieve the broken piece of the drill bit without any harm to the patient.We had to open up another latarjet set to get the 2.9mm glenoid cannulated drill bit from there to finish the surgery.The surgeon was able to complete the surgery successfully.No other information is available, including if there was a delay in surgery, whether fragments were generated, if there was any other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required, and if the patient is a part of a clinical study.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.Additional information: d4: the lot number was reported as unknown in the initial report and has been updated as 14a01.Therefore, udi: (b)(4).H4: the device manufacture date was reported as unknown in the initial report and has been updated as 2/27/2014.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the distal tip of the drill had been severed from the proximal portion of the device.It was also observed that the laser lines of the device are heavily faded.The device is reusable, and is currently 5 years old.It is possible that the distal end of the drill struck hard bone during use, therefore causing it to shear from the proximal end of the device.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.

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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BRIST-LATRJET GLNOID 2.9DRBIT
• Type of Device: NON-STERILE FLUTED SURGICAL DRILL, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8201088
• MDR Text Key: 131605066
• Report Number: 1221934-2018-55858
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886705022533
• UDI-Public: 10886705022533
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 285143
• Device Lot Number: 14A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1