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

Catalog Number	210821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2015
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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were 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 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.Associated medwatches: 1221934-2018-53683, 1221934-2018-53686.(b)(4).This report is being filed from the (b)(4) 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 by the sales rep that during a shoulder procedure three of their gryphon proknot peek shoulder anchors¿ suture separated multiple times, dividing into two on the first unloads.The surgeon used regular gryphons to complete the procedure with no delay and no patient consequences.The following additional information was received via phone by mitek complaints on (b)(6) 2015: the sales rep reported that the devices were discarded therefore will not be returning for evaluation.

• 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: 7750935
• Report Number: 1221934-2018-53684
• Device Sequence Number: 1703038
• Product Code: MAI
• UDI-Device Identifier: 10886705024049
• UDI-Public: 10886705024049
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K140643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2015

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: 09/30/2017
• Device Catalogue Number: 210821
• Device Lot Number: 3805389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2015
• Initial Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1