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 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.

• 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: 7836142
• MDR Text Key: 119333931
• Report Number: 1221934-2018-51811
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211036
• Device Lot Number: 1311524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1