MAUDE Adverse Event Report: DEPUY MITEK LLC US ABSOLUTE G-W NTNL 1.1MMX15 6PK; BONENAIL GUIDEWIRE

Model Number	254514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).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 affiliate in (b)(6) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that a guidewire 1.1mm x 15¿ device broke during insertion of femoral milagro screw.The broken wire was difficult to remove after the screw was inserted and an extra incision was required to remove the wire.There was a surgical delay of 10-15 minutes to complete the procedure.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 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.Investigation summary according to the information provided, it was reported that during an acl reconstruction a guidewire 1.1mm x 15¿ broke during insertion of femoral milagro screw.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However the customer provided a photo of the product label which contains the product code and the serial number, these numbers were verified, and they are correct.A second photo was provided which contains the image of the broken guide wire.A manufacturing record evaluation was performed for the finished device l936859 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 of the photo, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an entrapment of the guide wire at the moment of insertion was occurred, therefore the guide wire was broken.As per ifu 105494 ; if resistance is felt during the insertion of an absolute absorbable interference screw over a guide wire, stop and confirm that the guide wire is not entrapped.If entrapped, back out the screw and withdraw the guide wire.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: ABSOLUTE G-W NTNL 1.1MMX15 6PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11848804
• Report Number: 1221934-2021-01579
• Device Sequence Number: 3748117
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: 10886705013050
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/05/2021

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: 254514
• Device Catalogue Number: 254514
• Device Lot Number: L936859
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1