MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC PDS/PLA 2/0 PAN 27; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228312
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2013
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.The complaint devices were received and evaluated.Visually, it was observed that a small piece of suture, needle and the top hat were received for both devices.It was observed in both the cases that the suture is broken, confirming this complaint.Based on the fraying on the suture, it is possible that an instrument used in the procedure caused this failure.For example, if the instrument is used with a more abrasive suture than orthocord it may leave abrasions on the instrument, or if the instrument receives an impact on the distal tip, that also could leave a sharp edge on the instrument.Other than this possibility we cannot discern a root cause for this failure.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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 our affiliate the suture broke when the surgeon implanted the device.The surgeon tried a second suture, but the suture broke again.Finally, the surgeon tried another one and was able to complete the procedure.Please see also medwatch report 1221934-2018-50869.

• Brand Name: RAPIDLOC PDS/PLA 2/0 PAN 27
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7639118
• Report Number: 1221934-2018-50867
• Device Sequence Number: 2482328
• Product Code: MAI
• UDI-Device Identifier: 10886705010202
• UDI-Public: 10886705010202
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/08/2013

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: 06/01/2014
• Device Catalogue Number: 228312
• Device Lot Number: 3627819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2013
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1