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

Catalog Number	212859
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.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 product has not returned to depuy synthes, however a photo was provided for evaluation.¿ visual inspection of the returned photo found the device sitting on the desiccating tray.The drill bit and inserter had foreign matter, presumably biological residue.The anchor was detached from the inserter and the suture.No other anomalies were noted.As the device showed signs of use, the allegation of damage prior to use could not be confirmed.The overall complaint was confirmed as the observed condition of the microfix qa+#3/0 oc v-4 would have contributed to the complained device issue.¿ ¿ based on the investigation findings, the potential cause could be traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu-109285 as with any suture anchor device, care should be taken to avoid suture damage during insertion.Bony surfaces that may contact the suture should be smoothed to avoid nicking.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that before the surgery, the microfix qa+#3/0 oc v-4 was opened the packing(did not use), noted the suture was broken off.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that only the inserter and drill bit were returned for evaluation.The inserter and drill bit had foreign matter, presumably biological residue.As the device showed signs of use, the allegation of damage prior to use could not be confirmed.No other anomalies were noted.The overall complaint was not confirmed as the observed condition of the microfix qa+#3/0 oc v-4 would have not contributed to the complained device issue.Based on the investigation findings, the potential cause cannot be established since no defect was found.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: there was no non-conformance regarding this lot.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: MICROFIX QA+#3/0 OC V-4
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24092560
• Report Number: 1221934-2026-00261
• Device Sequence Number: 10238867
• Product Code: MAI
• UDI-Device Identifier: 10886705002481
• UDI-Public: (01)10886705002481(10)1031QS(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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 Catalogue Number: 212859
• Device Lot Number: 1031QS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 01/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/23/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown