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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US GRYPHON 2.4MM DRILL BIT SURGICAL HAND DRILL Back to Search Results
Catalog Number 211036
Device Problem Incorrect Measurement
Event Date 02/04/2014
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). Associated medwatch(s): [mr# 1221934-2018-51725]. 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 by dr. Had one gryphon (b)(4) break during a labral repair (shoulder) on a (b)(6). The surgeon had to spend 10 minutes to remove all broken anchor particles from the joint space. There were no patient consequences. He unloaded the suture from the first anchor and drilled over top of the same hole with the guide and 2. 4 gryphon drill bit and placed a new gryphon anchor without problem. Add'l info from rep drill bit (b)(4). Don't have lot number. All fragments were removed from the shoulder. 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.

 
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Brand NameGRYPHON 2.4MM DRILL BIT
Type of DeviceSURGICAL 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 Key7817203
Report Number1221934-2018-51727
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/04/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number211036
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2014
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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