MAUDE Adverse Event Report: MICRO QA+ #3/0 OC V4; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 212843

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during the surgery of flexor extensor tendon anastomosis, when opened the packing(did not use), noted the suture was broken off (as the photo shows).The complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo it was observed that the anchor is missing, one end of the suture is broken from the part that holds the needle.A manufacturing record evaluation was performed for the finished device 6l47204 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 can be confirmed.Multiple factors are associated with this type of failure, the photo provided does not contain enough evidence to determine a root cause.Hands on analysis should provide the evidence necessary to confirm the 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.

Event Description

It was reported by the affiliate in (b)(6) that during a flexor extensor tendon anastomosis procedure on (b)(6) 2021, it was observed that the suture on the micro qa+ #3/0 oc v4 device was broken off upon opening its package.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.H10 additional narrative: 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 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 : according to the information provided, it was reported that during the surgery of flexor extensor tendon anastomosis, when opened the packing(did not use), noted the suture was broken off (as the photo shows).The device was received and evaluated.Visual observations reveals that the anchor is out from the plastic sleeve, upon reviewing the suture, it was found that it has a breakage.A manufacturing investigation will be performed.A manufacturing record evaluation was performed for the finished device 6l47204 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, this complaint can be confirmed.The investigation was performed by the manufacturing department with the following results: an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also per tm-tm0091 rev45.The result of this process check is successful, none of the 9 parts were non-conformed.So there is no need to inspect more parts of the batch nor raise a non-conformance.According to pva-100912-pfmea product manufacturing process, the potential occurrence of having a deformed needle has been evaluated to 0 on (b)(4) sold units over 212843 from 2020 per work instruction corresponding to defect over parts.The suture strength is already identified in the pfmea.Resistance of assembly has been evaluated in the work instruction by combining probability and severity levels.With a ratio of 0% < 0.02% and is ranking 1 (= improbable and negligible).This risk is acceptable.A complaint research, with the same defect did not show another case with this issue from 2019 to now with the items reference 212843.No nr was found during the research.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The bounding is limited on this part as the complaint analysis shows that there is no other occurrence of such defect for this batch, the batch before and the batch after.A manufacturing investigation activity has been performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.There has been a closer look on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.Its been confirmed that the product is 100% visual inspected, also, the personnel involved in the process are completely certified in their activities.According with the investigation results, we can conclude this issue to be an isolated case.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: MICRO QA+ #3/0 OC V4
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• MDR Report Key: 12488240
• MDR Text Key: 271908064
• Report Number: 1221934-2021-02731
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002375
• UDI-Public: 10886705002375
• Combination Product (y/n): N
• PMA/PMN Number: K080352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 212843
• Device Catalogue Number: 212843
• Device Lot Number: 6L47204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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