MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROFIX QA+#3/0 OC V-4; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212859

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported by the sales rep in south korea that preoperatively to an unknown surgery on an unknown date, it was observed that the suture was separated on the microfix qa+ #3/0 ocord v-4 tapercut needles w/drill bit device.During in-house engineering evaluation of the photo received from the customer, it was determined that the implant and suture were detached from the tip at the distal end of the device.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 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).Reporter is a j&j sales representative.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.Investigation summary: a photo was received from the customer and evaluated.Upon visual inspection of the photo, the photo showed the implant and suture detached from the tip at the distal end of the device; therefore, this complaint can be confirmed.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: 8l06226, and no nonconformances were identified.The photo does not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause the transportation/storage issues.However, we cannot conclusive affirmed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.

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 device was received and evaluated.Upon visual inspection, it was found that the anchor is detached from the inserter tip.On magnification the inserter tip was found bent.The anchor hole in which the inserter tip goes inside was found damaged.A manufacturing record evaluation was performed for the finished device 8l06226 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.According with the visual inspection result, this complaint cannot be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive pressure force may was applied with the fingers on the foil pouch when it was opened, therefore the anchor was forced to separate from the inserter tip, however, this cannot be conclusively determined.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: MICROFIX QA+#3/0 OC V-4
• Type of Device: 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: 15879818
• MDR Text Key: 306923302
• Report Number: 1221934-2022-03795
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002481
• UDI-Public: 10886705002481
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,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: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 212859
• Device Catalogue Number: 212859
• Device Lot Number: 8L06226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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