MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRIFXQA+ W/#4OC C1; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212045
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Visual observation reveals that the distal end of the inserter shaft is bent.Also, the anchor is off the inserter but held in place by the suture.The suture was still intact and was not frayed or cut.This complaint can be confirmed.No further procedural details were provided that could determine a root cause for the reported failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.A manufacturing investigation was conducted since the failure occurred out of package and the manufacturing process was performed according to the procedures without any issue.A review into the depuy synthes mitek complaints system revealed one similar complaint for this lot of devices that were released to distribution.At this point in time, 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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported from (b)(6) that at pre-surgery, it was observed that the cap on the micrifxqa+ w/#4oc c1 was found detached from the rod.It was further reported that the rod tip was bent when the device was retrieved from the package.The incident did not cause a delay in the surgery.There was no patient involvement.There were no reports of injury, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should be become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: MICRIFXQA+ W/#4OC C1
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8994986
• Report Number: 1221934-2019-58254
• Device Sequence Number: 16212280
• Product Code: MAI
• UDI-Device Identifier: 10886705001903
• UDI-Public: 10886705001903
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 212045
• Device Lot Number: L384716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1