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

Model Number 211036

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the gryphon 2.4mm drill bit device was extremely dull.Another like device was used to complete the procedure with an unspecified slight delay.There were no adverse patient consequences reported.No additional information was provided.

• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12123350
• MDR Text Key: 260108087
• Report Number: 1221934-2021-02094
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 211036
• Device Catalogue Number: 211036
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1