MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON P BR DSW PERMACORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	223147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2015
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 this complaint is being closed since after multiple email attempts to retrieve the product, the product still hasn't been returned for evaluation.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the 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.(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
The sales rep reported that during a rotator cuff repair that the nose of the anchor broke/cracked and the suture pulled out leaving the anchor securely implanted within the bone.The surgeon completed the procedure leaving the anchor in the bone with no patient consequences or delay.The sales rep reported that the surgeon did not use any additional anchors to finish the procedure.The patient was a male in his (b)(6) with good bone quality.

• Brand Name: GRYPHON P BR DSW PERMACORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7750140
• Report Number: 1221934-2018-54054
• Device Sequence Number: 1678944
• Product Code: MAI
• UDI-Device Identifier: 10886705024612
• UDI-Public: 10886705024612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141259
• 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): 05/20/2015

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: 223147
• Device Lot Number: 3803043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2015
• Initial Report FDA Received Date: 08/05/2018
• Patient Sequence Number: 1