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

Catalog Number	254628
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.E3: reporter is a j&j sales representative.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Investigation summary: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Upon visual inspection of the photo, it was observed that two sheets are shown, the on in the lefts side is broken into three pieces.The second in the right side is broken, however the missing broken pieces are not shown.These devices are not identified with their corresponding lot numbers.A manufacturing record evaluation was performed for the finished device lot 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.Based on the visual inspection findings, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; the screw may not have been inserted along the tunnel and consequently cause damage to the sheath.As per instructions for use (ifu); failure to insert the screw along the tunnel axis may result in device damage.Guidewire use is recommended.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.
Event or Problem Description
It was reported by the sales rep in china that during an anterior cruciate ligament (acl) repair procedure performed on (b)(6) 2023, when the physician implanted the biointrafix "tibial" sh lrg 30mm sheath into the body, the sheath broke into several pieces.The surgeon changed to another biointrafix "tibial" sh lrg 30mm sheath and the same problem occurred.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for the same event in (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: additional information b5: upon further investigation additional information was obtained from the sales rep.It was reported that all of the broken pieces of the device were removed from the patient, and the patient is in stable condition.
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.
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 the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the anchor is broken on four parts vertically; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no nonconformances were identified.A possible root cause can be attributed to a procedural variable, such handling of the device or product interaction during procedure; the screw may not have been inserted along the tunnel and consequently cause damage to the sheath.However, this cannot be conclusively determined.As per instructions for use (ifu); failure to insert the screw along the tunnel axis may result in device damage.Guidewire use is recommended.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: BIOINTRAFIX TBIAL SH LRG 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: 18418383
• Report Number: 1221934-2023-04778
• Device Sequence Number: 18133783
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 254628
• Device Lot Number: 160L832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 01/22/2024; 02/01/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/09/2024; 01/23/2024; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown