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

Catalog Number 212865

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(4) that during finger ligament repair surgery, it was observed that the suture thread broke.The surgery was completed by using alternative device (same p/n with an unknown lot number).The surgeon confirmed that there was no damage before it was inserted to the patient¿s body.It was brand new and the first use when the issue occurred.There was less than 30 min.Surgical delay and no harm to the patient.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not being returned, it was discarded by the customer or multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code 212865 lot l717617 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).Device available for evaluation, device evaluated by manufacturer.

• Brand Name: MICRO QA+ #3/0 ETH V-4
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8102082
• MDR Text Key: 128290322
• Report Number: 1221934-2018-55374
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• PMA/PMN Number: K024115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 212865
• Device Lot Number: L717617
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1