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

Model Number	228312
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2013
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.Mitek received the complaint device and evaluated it visually.Visually, it was observed that the suture with top hat still loaded was received and the suture is broken, confirming this complaint.The suture was examined closely under magnification and with the exception of breakage no other anomalies like fraying were observed.The structure of the suture appears intact.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 we cannot discern a root cause for the reported failure.Based on the overall complaint rate for this failure, 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 when the surgeon released the system, the fixation went through the meniscus and the suture ruptured.The surgery was finished successfully with a same like product.

• 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: 7688490
• Report Number: 1221934-2018-51320
• Device Sequence Number: 10950664
• Product Code: MAI
• UDI-Device Identifier: 10886705010202
• UDI-Public: (01)10886705010202(10)3666430(17)150131
• 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): 08/09/2013

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: 01/31/2015
• Device Model Number: 228312
• Device Catalogue Number: 228312
• Device Lot Number: 3666430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2013
• Initial Report FDA Received Date: 07/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1