MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC PLA /PLA 2/0 PAN 12; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228321
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot number is currently unavailable; therefore, the exp date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 3 of 4 for the same event.It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that while using rapidloc anchor, the surgeon was only successful in one of them and complained that the thread was very fragile since it broke before finishing the suture adjustment.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Product complaint#: (b)(4).Investigation summary: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate associated medwatch report numbers: 1221934-2018-54968, 1221934-2018-54967, 1221934-2018-54969.

• Brand Name: RAPIDLOC PLA /PLA 2/0 PAN 12
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7973286
• Report Number: 1221934-2018-54966
• Device Sequence Number: 16457598
• Product Code: MAI
• UDI-Device Identifier: 10886705010226
• UDI-Public: 10886705010226
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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 Catalogue Number: 228321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 12/01/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1