MAUDE Adverse Event Report: DEPUY MITEK LLC US BIO-INTRAFIX TIBIAL SHEATH - LARGE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254628
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
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.Additional narrative: udi: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.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
This is report 1 of 2 for (b)(4).It was reported by the sales rep in china that a patient underwent an arthroscopic reconstruction procedure for anterior cruciate ligament injury on (b)(6) 2022; and was implanted with two biointrafix implants; bio-intrafix tibial sheath - large device and bio-intrafix tapered screw, 7-9 mm x 30 mm device.According to the report, the patient developed rejection with persistent low-grade fever three months after the initial procedure.It was further reported that a second surgery was undergone to remove the implants on (b)(6) 2023.And the peek implants were replaced for implanting.It was reported that the patient was in stable condition now.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 a appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the biointrafix sheath (254628) is shown inside a transparent plastic bag.No structural anomalies can be observed, however, a little part of the sheath is broken due to the removal procedure.The device has biological matter on its body which is a sign that it was removed from the patient's body.A manufacturing record evaluation was performed for the finished device 9l05327 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.Since there is no allegation against the product, we cannot determine a root cause for the reported issue.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.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.Investigation summary: the complaint devices were received and evaluated.Upon visual inspection, the screw is inserted into the sheath.No structural anomalies can be observed, however, a little part of the sheath is broken due to the removal procedure.The devices have biological matter on their body which is a sign that it was removed from the patient's body.A manufacturing record evaluation was performed for the finished device 9l05327 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.Since there is no allegation against the product, we cannot determine a root cause for the reported issue.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: BIO-INTRAFIX TIBIAL SHEATH - LARGE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 16373532
• Report Number: 1221934-2023-00744
• Device Sequence Number: 6748847
• Product Code: HWC
• UDI-Device Identifier: 10886705013241
• UDI-Public: 10886705013241
• 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,Health Professional,User Facility,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 254628
• Device Catalogue Number: 254628
• Device Lot Number: 9L05327
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 02/20/2023; 03/10/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/17/2023; 02/21/2023; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown