MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX TBIAL SH SM 30MM; SCREW, FIXATION, BONE

Catalog Number	254629
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from the sales rep in china that during an anterior cruciate ligament procedure on 11/24/23 the biointrafix tbial sh sm 30mm device slipped during the surgery and couldn't be tightened.After repeated tightening attempts, the wound was closed and closed the surgery.Post op, laxity was noted in post-operative physical examination.Radiographic examination revealed that the rigidloop adjustable implant was positioned in the muscle layer and failed surgical fixation.Patient underwent an acl revision procedure.The patient was in stable condition now.No further information was provided.This is report 3 of 3 for (b)(4).
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.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.E3: reporter is a j&j sales representative.D4, h4: the device serial/lot number and manufacture date are unknown.Udi: (b)(4) incomplete.D10, concomitant medical devices and therapy dates, rgdloop adjustable stnd and biointfx 6-8mmx30mm tpr scr 2nd, (b)(6) 2023.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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.Device was used for treatment, not diagnosis.H10 additional narrative: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information 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.

• Brand Name: BIOINTRAFIX TBIAL SH SM 30MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18310443
• Report Number: 1221934-2023-04528
• Device Sequence Number: 20512898
• Product Code: HWC
• UDI-Device Identifier: 10886705013258
• UDI-Public: 10886705013258
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• 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
• Report Date (Section B): 12/12/2023

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 Catalogue Number: 254629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown