MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET GLENOID LONG DRILL BIT 3.2; SURGICAL HAND DRILL

Model Number 285300

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: to date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a latarjet procedure the glenoid 3.2mm drill was dull.Another device was used to complete the procedure.No patient consequences, or surgical delay reported.It is unknown if the device is available to be returned for evaluation.Additional information received from the sales representative reported the device will not be returned because it was discarded by hospital staff.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (18e01), and no non-conformances were identified.At this point in 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 as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: LATARJET GLENOID LONG DRILL BIT 3.2
• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10710564
• MDR Text Key: 212257522
• Report Number: 1221934-2020-03104
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705018093
• UDI-Public: 10886705018093
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 285300
• Device Catalogue Number: 285300
• Device Lot Number: 18E01
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1