MAUDE Adverse Event Report: DEPUY MITEK MINI QUICK ANCHOR PLUS, W/ #0 ORTHOCORD & OS-2 NEEDLE W/BIT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer 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 was received and evaluated.Visual observation reveals that the anchor is off the inserter and the sutures were released off the suture card.The anchor was examined under magnification, and no damage or structural anomalies were found.The suture was not damaged or frayed.Moreover, no anomalies were found with the inserter.The anchor was not bent, as reported; therefore this complaint cannot be confirmed.A batch record review has been conducted and the results indicate that this batch of product was processed with one unrelated incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaint for this lot released to distribution.A definite root cause for this failure cannot be determined.At this point in time, based on the complaint rates for this failure, 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.(b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the mini quick anchor plus, w/ #0 orthocord & os-2 needle w/bit was broken.According to the report, the event occurred when the surgeon placed the anchor during a correction of proximal radius fracture.It was reported that the surgeon changed to another anchor device to complete the procedure.It was not reported if there were any delays in the surgical procedure.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.

• Brand Name: MINI QUICK ANCHOR PLUS, W/ #0 ORTHOCORD & OS-2 NEEDLE W/BIT
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7772701
• Report Number: 1221934-2018-53842
• Device Sequence Number: 1392417
• Product Code: JDR
• UDI-Device Identifier: 10886705001866
• UDI-Public: 10886705001866
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2015

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: 04/30/2017
• Device Catalogue Number: 212038
• Device Lot Number: 3778240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2015
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1