MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 6.5 MM ANCHOR, W/ ORTHOCORD - W/O NEEDLES; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222994

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

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 is not being returned, therefore is unavailable for a physical evaluation.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 similar complaints for this lot released to distribution.We cannot discern a root cause for the reported failure mode.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).

Event Description

It was reported by the affiliate in (b)(6) that during rotator cuff repair surgical procedure, it was observed that the violet fastin rc 6.5 mm anchor, w/ orthocord - w/o needles broke off when used with expresssew gun (w/ needle inserted).It was reported that the procedure was completed by using just one suture on the anchor.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.

• Brand Name: FASTIN RC 6.5 MM ANCHOR, W/ ORTHOCORD - W/O NEEDLES
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7812523
• MDR Text Key: 118113590
• Report Number: 1221934-2018-53906
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705008728
• UDI-Public: 10886705008728
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 222994
• Device Lot Number: 3741195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1