MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL DRILLPN W/EYE .094X14" *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	219321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2023
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 medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.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 healthcare professional in france that during an unknown procedure on (b)(6) 2023, a drill pin w/eyelet.094x14 device was used.According to the report, the threaded end on the device broke off at the tibial tunnel; and became lodged in the patient's diaphyseal shaft.It was reported that the surgeon decided to leave the metal fragment in the patient's bone.It was unknown how the procedure was completed.There were no adverse patient consequences nor surgical delay 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.H10 additional narrative: d9, h3, h6: 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 medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.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 device was evaluated.Visual inspection revealed that the pin was broken, the broken piece was not returned.The broken end shows deformation curves due to the bending force.A manufacturing record evaluation was performed for the finished device lot 2112002 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.Based on the visual inspection findings, this complaint can be confirmed.A possible root cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure; the pin may have become entrapped and the excessive force applied to the pin at the moment of manipulating could have caused the pin breakage, 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.
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received.It was reported that the device was not in intra-articular.There was no additional medical or surgical intervention required.There were no complications to the patient.

• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17452593
• Report Number: 1221934-2023-02938
• Device Sequence Number: 20702581
• Product Code: NBH
• UDI-Device Identifier: 10886705005727
• UDI-Public: 10886705005727
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Catalogue Number: 219321
• Device Lot Number: (10)2205005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 08/20/2023; 08/25/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/16/2023; 08/22/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown