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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 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. A batch record review has been conducted and the 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 reported from the same facility for this lot of devices that were released to distribution. 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 medwatches: 1221934-2018-51809, 1221934-2018-51810. (b)(4).

 
Event Description

This complaint was opened to document one of six complaints reported by our sales rep. The rep reported that during a shoulder repair that the customer's gryphon drill bit broke the customer¿s anchor while it was being inserted into the bonehole. The sales rep reported that the drill bit was too short causing the anchor to fracture proximally. The surgeon completed the procedure with the device leaving the anchor securely contained within the bone hole and removing the broken pieces. The sales rep confirmed that there were no patient consequences and a 2 minute delay. The sales rep could not provide further information at the time. Please reference complaint# (b)(4) for the 6 additional procedures.

 
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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 Key7836142
Report Number1221934-2018-51811
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 02/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number211036
Device LOT Number1311524
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/28/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/08/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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