MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON T BR ANCHOR W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.
Event or Problem Description
Upon insertion of gryphon br anchor into glenoid performed by doctor, gryphon anchor broke.Another anchor was opened and surgery continued with little delay and no adverse events to patient.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Event or Problem Description
Upon insertion of gryphon br anchor into glenoid performed by doctor, gryphon anchor broke.Another anchor was opened and surgery continued with little delay and no adverse events to patient.No patient consequence.Spoke with the sales rep for additional information on this complaint.The first grypon anchor broke in more than 2 pieces when the surgeon removed the inserter.All fragments were removed, and the surgeon used another gryphon anchor that pulled out once inserted.The surgeon then used a lupine anchor in the same bone hole to complete the procedure.There were no patient consequences or delays.The customer discarded the devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.Pictures were not provided.This complaint is not confirmed.The initial report stated that the implant broke after inserting in the bone hole, when removing the inserter.No further procedure information was provided to determine if the above reason contributed to this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review of the depuy synthes mitek complaints system revealed three similar complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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).

• Brand Name: GRYPHON T BR ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7601353
• Report Number: 1221934-2018-51846
• Device Sequence Number: 19349716
• Product Code: MAI
• UDI-Device Identifier: 10886705001262
• UDI-Public: 10886705001262
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 07/31/2020
• Device Catalogue Number: 210812
• Device Lot Number: L502513
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1