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

Catalog Number	210031
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2014
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 the complaint device is not being returned, therefore 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 mitek complaints system revealed no other complaints 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 further action is warranted.However, 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.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 a hip repair that her hip knot manipulator was cutting suture when the knot was being pushed down.The sales rep reported that the device cut the suture of 2 of the anchors, one close to the anchor leaving no suture left to tie it and the other 1/4 of the way down the suture allowing the surgeon to use this anchor to secure the fixation.Both anchors were left securely in the boneholes.The surgeon completed the procedure with the device with no patient consequences or delays.The sales rep could not provide the lot number for the manipulator at this time but will retrieve it from the facility.The sales rep reported that the customer does not use fiberwire.See also, manufacturer report number: 1221934-2018-52113.

• Brand Name: GRYPHON PEEK ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7813881
• Report Number: 1221934-2018-52112
• Device Sequence Number: 13879011
• Product Code: MAI
• UDI-Device Identifier: 10886705019946
• UDI-Public: 10886705019946
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2014

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: 09/30/2016
• Device Catalogue Number: 210031
• Device Lot Number: 3731561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2014
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1