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	03/15/2018
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.(b)(4).The expiration date is not currently available.
Event or Problem Description
It was reported by the sales rep that the suture bridge broke on the customer's rapidloc 2/0 paracryl 27 degree while tightening the suture.The customer used another rapidloc 2/0 paracryl 27 degree and the device would not tighten during a meniscal repair.The case was completed with a third like device.There were no patient consequences or damage to the meniscus but a 5 minute delay was reported.The devices were discarded by the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded and not available for evaluation.There is no information about the surgery suggesting the failure of the device.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.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.Further, a review into the depuy mitek complaints system revealed no other complaints 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.Udi: (b)(4).

• 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: 7423138
• Report Number: 1221934-2018-50445
• Device Sequence Number: 18841532
• Product Code: MAI
• UDI-Device Identifier: 10886705010202
• UDI-Public: 10886705010202
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2018

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: 08/31/2018
• Device Catalogue Number: 228312
• Device Lot Number: 3928672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 06/30/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1