MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON DRILL BIT; SURGICAL HAND DRILL

Model Number	211036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 , a follow-up will be filed as appropriate.Udi: (b)(4).The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Reporter is a j&j employee.To date the device has not been returned.If the device or further details are received at a later date a supplemental will be sent.
Event or Problem Description
It was reported by the affiliate in japan that during an arthroscopic bankart repair procedure on (b)(6) 2023, it was observed that the gryphon drill bit device broke during drilling.The broken drill bit was removed completely from the patient's body.It was unknown how the procedure was completed within 30 minutes delay.There were no adverse patient consequences reported.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 medatch will be filed as appropriate.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation revealed that the device appears to be heavily used, there are wear marks in the entire device.The sharp tip at the distal end and the drill were found with a lot scratches.Finally, the device was broken, the drill collar and the drill shaft were separated.This complaint can be confirmed.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The possible root cause for the reported failure can be related to procedural variables, such handling of the device or product interaction during procedure as well as rough use by the user.The condition of the tip could be attributed to the wear and tear of the device; moreover when the device was tapped against a hard surface accidentally.This failure has possibly occurred after using it in this manner for many procedures.As per ifu, end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Clean delicate instruments separately from other instruments.Visually inspect the instrument and check for damage and wear.Cutting edges should be free of nicks and have a continuous edge.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: GRYPHON DRILL BIT
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16313297
• Report Number: 1221934-2023-00663
• Device Sequence Number: 17711959
• Product Code: HTW
• UDI-Device Identifier: 10886705001484
• UDI-Public: 10886705001484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 Model Number: 211036
• Device Catalogue Number: 211036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 02/21/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/13/2023; 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male