MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 212035

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/09/2022

Event Type  malfunction  

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 Description

It was reported by sales rep that during an unknown procedure on (b)(6) 2022, it was observed that a mini qa+ w/ #2/0 ocord and v-5 needle w/bit initially pulled out during the first attempt at setting the anchor when it was inserted into the 5th distal phalanx to reattached the extensor tendon.According to the report, after pulling out the first time, the anchor was reset onto the inserter, the bone was drilled again and the anchor was inserted and set successfully within the bone and the surgeon confirmed that fixation was achieved radiographically.The repair was completed on a second attempt after the anchor.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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary
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> the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (8l67512), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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: MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT
• Type of Device: SOFT-TISSUE ANCHOR, NON-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: 15372240
• MDR Text Key: 306161206
• Report Number: 1221934-2022-02679
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001835
• UDI-Public: 10886705001835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212035
• Device Catalogue Number: 212035
• Device Lot Number: 8L67512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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