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 Codes	Inflammation (1932); Foreign Body In Patient (2687)
Date of Event	01/21/2021
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 affiliate in (b)(6) that postoperatively to an anterior cruciate ligament reconstruction procedure performed on (b)(6) 2021, it was observed that a fragment of the absolute g-w ntnl 1.1mmx15 6pk device remained inside the patient and began to come out little by little through the cannulation of the implanted screw device.On (b)(6) 2021, the patient underwent another surgical intervention to extract the fragment.The patient presented inflammation.The fragment was removed from the patient.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.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 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 received, it was reported that a patient underwent the surgical procedure for the reconstruction of the anterior cruciate ligament.The surgery was performed on (b)(6) 2021.The procedure went smoothly.The patient arrives after surgery for his check-up appointment and the doctor identifies something unusual, a fragment of the absolute g-w ntnl 1.1mmx15 6pk remained inside the patient and began to come out little by little through the cannulation of the 11x30 mm advance miracle screw implanted.The patient underwent another surgical intervention to extract the fragment of the nitinol guide ref 254514.Patient presented inflammation.The fragment is removed from the patient and is available for studies.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.The returned device was visual inspected, the observations revealed that the nitinol guide wire was broken.Only 2.1 inches of the nitinol guide was received; the distal part was bent, and some scratches were identified.A manufacturing record evaluation was performed for the finished device lot number: 6l65989, and no nonconformances were identified.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 600 devices that were released to distribution.No further procedural details were provided that could determine a root cause for the reported failure.Product evaluation of the returned device indicates that the nitinol guide wire could have being jammed during the insertion of the screw over the wire, this would cause that the force applied to deform the guide and then broke.It is possible that did not notice the broken part during the surgery.However, it cannot be conclusively affirmed.  as per ifu- 105494, indicates that if resistance is felt during the insertion of an absorbable interference screw over the guide wire, stop and confirm that the guide wire is not entrapped.If entrapped, back out the screw and withdraw the guide wire.And follow the instructions to pull back the guide wire and avoid any damage, it is important to rotate the hex driver counterclockwise to back out the screw until the guide wire straightens, however; it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: 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: 11740338
• Report Number: 1221934-2021-01377
• Device Sequence Number: 4168231
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: 10886705013050
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2021

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 Expiration Date: 12/31/2022
• Device Model Number: 254514
• Device Catalogue Number: 254514
• Device Lot Number: 6L65989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 06/12/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/01/2021; 06/14/2021
• 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