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 Fragmentation (1261)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The exp date is currently unavailable.Investigation summary: the complaint device was not returned by the customer the implant device was left embedded in the patient's bone therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the suture bridge is damaged.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part#: 210821 lot#:1l85497 combination and no nonconformances were identified.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.
Event or Problem Description
It was reported by the sales rep via cst that during an arthroscopic shoulder stabilization the customer's gryphon peek anchor with proknot unloaded while pulling the inserter out.The sales rep stated that the card was still attached to one end and the free end didn't get pulled through the anchor.The sales rep stated that it seemed like the suture bridge on the anchor was defective.The case was completed with another anchor in a different location with a one minute delay.The sales rep stated there is no need for surgical intervention.The sales rep stated that other anchors in the same lot had no problems, but the sales rep did not provide a lot number.There was patient involvement reported.It was not reported if there was a prolonged hospitalization.The patient's status post-surgery was unknown.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: 8206261
• Report Number: 1221934-2018-55877
• Device Sequence Number: 1997015
• Product Code: MAI
• UDI-Device Identifier: 10886705024049
• UDI-Public: 10886705024049
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 210821
• Device Lot Number: 1L85497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention