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

Model Number	285300
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a latarjet procedure on (b)(6) 2021, it was observed that the latarjet glenoid long drill bit 3.2 device was difficult to pass through the bone.The surgeon proceeded to finish with an open surgery with a delay of 1 hour and 30 minutes; and with part of the rest of one of the bone plugs that remained and fixing with a single latarjet screw.The current status of the patient was unknown.No additional information was provided.
Additional 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: according to the information provided, it was reported that the drill bits of the latarjet system, difficult to pass over the bone.Which made the surgery difficult.The device was received and evaluated.Visual observations reveals that the device has some marks of wear and use as usual on these type of reusable devices.The device does not show any structural anomalies on the shaft.On magnification at the drill bit, it was observed that the edges are dull.A manufacturing record evaluation was performed for the finished device 16e01 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to the constant and rough use.Since this is a reusable device, the constant manipulation between surgeries, the repeated drilling and sterilization process can lead in drill bit degradation, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: LATARJET GLENOID LONG DRILL BIT 3.2
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11820096
• Report Number: 1221934-2021-01534
• Device Sequence Number: 3149207
• Product Code: LXH
• UDI-Device Identifier: 10886705018093
• UDI-Public: 10886705018093
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 285300
• Device Catalogue Number: 285300
• Device Lot Number: 16E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention