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

Model Number	254514
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Foreign Body In Patient (2687); No Code Available (3191); Swelling/ Edema (4577)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot number is unknown at this time.
Event or Problem Description
It was reported by affiliate via complaint submission tool, the absolute g-w ntnl 1.1mmx15 6pk.The procedure was an anterior cruciate ligament reconstruction.When the patient went to the control, he expressed that he had pain.Upon examination, the doctor detected a lump, subjected it to an x-ray and it was detected that a fragment of the nitinol guide had remained.I do not know how much time passed between the consultation and the removal of the material.The patient did not present any type of adverse reaction and the fragment could be removed successfully.According to the technical assistant, the nitinol guide in question was not ours but the doctor's own.The patient had to undergo a minor surgical procedure.There was inflammation and pain.The device is available to be returned for evaluation.
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 patient presented pain and upon examination, the doctor detected a lump.Thru a x-ray analysis, a fragment of the nitinol guide was detected.The patient did not present any type of adverse reaction and the fragment could be removed successfully.The complaint device was not returned, despite the multiples attempts for product return, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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 during an anterior cruciate ligament reconstruction.When the patient went to the control, he expressed that he had pain.Upon examination, the doctor detected a lump, subjected it to an x-ray and it was detected that a fragment of the nitinol guide had remained.I do not know how much time passed between the consultation and the removal of the material.The patient did not present any type of adverse reaction and the doctor has the fragment product.According to the technical assistant, the nitinol guide in question was not ours but the doctor's own.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 and 3.4in was received as well as some scratches were found along the wire.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.No information was provided on how or when the failure has occurred; therefore, no definitive root cause could be determined.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 can broke.It is possible that the surgeon may not have noticed that a part of the guide wire was broken.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.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.
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: 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.

• 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: 10557552
• Report Number: 1221934-2020-02683
• Device Sequence Number: 11647281
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: 10886705013050
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 254514
• Device Catalogue Number: 254514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 03/12/2021; 03/21/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/13/2020; 03/15/2021; 03/22/2021
• Patient Sequence Number: 1