MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON 2.4MM DRILL BIT; SURGICAL HAND DRILL

Catalog Number 211036

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2014

Event Type  malfunction  

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 devices were received and evaluated.The dimensional inspection confirmed the drill bit was out of specification and the failure was attributed to human error during manufacturing.Nc has been initiated at mitek to capture supplier capa for this issue.Appropriate measures and corrective actions were implemented to mitigate this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.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.(b)(4)-incomplete.Associated medwatch(s): 1221934-2018-51742, 1221934-2018-51743, 1221934-2018-51744, 1221934-2018-51746, 1221934-2018-51747.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 Description

It was reported that dr.Xxxxxxxx had 3 gryphon anchors #210814 break during shoulder surgery in a 18 year old.The tops of all three anchors fractured off upon inserting them with a mallet into the properly drilled hole through the drill guide.The surgeon had to spend time to remove the lose anchor bodies from the joint with delayed surgery.There was no patient consequence and the doctor left all the anchors in the bone.Sales rep stated the case was delayed five minutes.Additional info based on feedback from our marketing department, the drill bits should have been included.See related complaint (b)(4).Customer is sending back the 5 drill bits in their inventory for evaluation.

• Brand Name: GRYPHON 2.4MM DRILL BIT
• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7817180
• MDR Text Key: 118753706
• Report Number: 1221934-2018-51745
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886705001484
• UDI-Public: 10886705001484
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1