MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ O/C DS CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222984

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The complaint device is not being returned, therefore unavailable for a physical evaluation.A non-conformance search was performed for this product code 222984-lot #l266162 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.Furthermore, a review into the depuy synthes mitek complaints system revealed no similar complaint for this lot of devices that were released to distribution.As a result, we cannot discern a root cause for the reported failure mode.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.

Event Description

It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the super qa+ o/c ds cp-2, ea device broke during use.According to the reporter, the anchor part was already countersunk in the bone and therefore nothing could be done.The surgeon proceeded with the surgery and only use one suture (the non broken one) to continue to repair the atfl ligament.It was reported that overall, the surgeon was quite satisfied; but he did mention that the stability was compromised as one long strand of suture was broken.However, he managed to fix the other strand well.The surgeon did not need to add another anchor or do something else because of this failure.The surgeon was reported to have improvised in terms of tying the suture knot.There was delay of 15-20 minutes.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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8278024
• MDR Text Key: 134878908
• Report Number: 1221934-2018-53832
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705008629
• UDI-Public: 10886705008629
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K052631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 222984
• Device Lot Number: L266162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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