MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON PEEK W/PROKNOT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	210821
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2013
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.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 as related to the reported problem.Further, a review into the depuy mitek complaints system revealed similar complaints for this lot released to distribution.A capa and a non-conformance have been opened to document the non conformance and this failure investigation relating to this failure mode.Udi: (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 that during an unspecified surgical procedure, the patient had an extremely loose capsule so the surgeon and fellow did a capsular shift.The first anchor was placed and a large bite of tissue was taken, repair completed correctly and sutures cut.When the fellow used the arthrex suture lasso to bite the next section of tissue for the next anchor, the half hitch on the first pro-knot popped through the cinch port of the knot and the knot construct came undone.Surgeon and fellow placed second anchor and repaired the second portion of tissue, when tying the half-hitch the fellow broke a strand of suture at the knot.Surgeon then had the fellow drill through the first pro-knot which sat inferior to the second and placed another anchor which had no issues.There were a total of four anchors were placed to finish the repair.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: GRYPHON PEEK W/PROKNOT
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7800910
• Report Number: 1221934-2018-51500
• Device Sequence Number: 1116752
• Product Code: MAI
• UDI-Device Identifier: 10886705024049
• UDI-Public: 10886705024049
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2013

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: 08/01/2016
• Device Catalogue Number: 210821
• Device Lot Number: 3728740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2013
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1