MAUDE Adverse Event Report: DEPUY MITEK LLC US BIO-INTRAFIX TAPERED SCREW, 8-10 MM X 30 MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254625
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in china that during an acl (ant.Cruciate ligament) reconstruction procedure on (b)(6) 2022, it was observed that the bio-intrafix tapered screw, 8-10 mm x 30 mm anchor device had a crack on it.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be 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 as appropriate.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.
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 fo the initial medwatch, a follow-up medwatch will be filed as 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 photo shows the bio-intrafix cracked at the middle of the tapered screw.Also, it could be observed biological residues on the anchor.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device lot number: 8l45054, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.The broken tapered screw can be attributed to procedural variables, such handling of the device or product interaction during procedure.The possible root cause could be related to a failure to engage until fully seated position of the tapered screw during implantation.However, it cannot be conclusively affirmed.As per ifu, should insert hex driver into tapered screw to a fully seated position.Failure to engage screw completely may result in damage to tapered screw during implantation.Do not insert a 6¿8 mm screw into a tunnel less than 8 mm in diameter.Use the hard bone sizing with tibialis allografts.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.
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 device was received and evaluated.Visual inspections revealed marks of use on the device.It could be observed the bio-intrafix was broken into two pieces at the middle of the tapered screw.Also, it could be observed biological residues on the anchor.A manufacturing record evaluation was performed for the finished device lot number: 8l45054, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The broken tapered screw can be attributed to procedural variables, such handling of the device or product interaction during procedure.The possible root cause could be related to a failure to engage until fully seated position of the tapered screw during implantation.However, it cannot be conclusively affirmed.As per ifu, should insert hex driver into tapered screw to a fully seated position.Failure to engage screw completely may result in damage to tapered screw during implantation.Do not insert a 6¿8 mm screw into a tunnel less than 8 mm in diameter.Use the hard bone sizing with tibialis allografts.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: BIO-INTRAFIX TAPERED SCREW, 8-10 MM X 30 MM
• 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: 14711210
• Report Number: 1221934-2022-01767
• Device Sequence Number: 11313180
• Product Code: HWC
• UDI-Device Identifier: 10886705013227
• UDI-Public: 10886705013227
• 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
• Report Date (Section B): 06/15/2022

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: 08/31/2024
• Device Model Number: 254625
• Device Catalogue Number: 254625
• Device Lot Number: 8L45054
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 07/21/2022; 07/26/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/27/2022; 07/22/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Sex: Unknown