MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-9MMX30MM TPRSCR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 254624

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 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.

Event Description

It was reported by the customer in china that during a knee surgery on (b)(6) 2022, it was observed that the anchor on the biointrafix 7-9mmx30mm tprscr device was cracked.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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 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 top where the hex driver is inserted, the crack ends up to the middle of the tapered screw.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#: 8l58086.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.Hands on analysis should provide more evidence to be able to discern a root cause.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.

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.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.

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 e filed as appropriate.Investigation summary: the complaint device was received and evaluated.Upon visual inspection, it could be observed the anchor broken and biological residues on it.A manufacturing record evaluation was performed for the finished device lot number: 8l58086, 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.Hands on analysis should provide more evidence to be able to discern a root cause.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 7-9MMX30MM TPRSCR
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14337121
• MDR Text Key: 291213179
• Report Number: 1221934-2022-01347
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705013210
• UDI-Public: 10886705013210
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 254624
• Device Catalogue Number: 254624
• Device Lot Number: 8L58086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1