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 Code	Not Applicable (3189)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).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 or Problem Description
It was reported by the affiliate in (b)(6) that after drilling the glenoid during an arthroscopic laterjet, it was observed that upon removal of the drill, it left behind the distal tip that appeared to have cleanly snapped at the junction where the drill bit thins (approx 5cm) out.Affiliate stated that it was removed with other standard arthroscopic instrumentation without any harm to the patient.The case was completed by the removal of it using the needle holder.There was a three minute surgical delay reported.Affiliate added that there were no fragments generated and no medical intervention required.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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the distal tip of the device was separated from the proximal end at the weld point.It is possible that the device hit hard bone while in use therefore causing torsional strain at the distal tip weld point.When excessive torsional strain occurs at the distal tip, the device may separate the weld point observed therefore is a potential root cause for the reported failure.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.Udi: (b)(4).
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.Correction: the lot number was reported as 205734133.In the initial report and has been updated as 16e04.Therefore, udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8212199
• Report Number: 1221934-2019-55889
• Device Sequence Number: 11449491
• Product Code: HTW
• UDI-Device Identifier: 10886705027316
• UDI-Public: 10886705027316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2018

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: 16E04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/11/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/04/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1