MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON HARD BONE DRILL; CANNULATED SURGICAL DRILL

Catalog Number	211601
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the sales rep via phone that following a shoulder repair procedure the sales rep's gryphon hard bone drill was dull.The sales rep stated the patient had a hard bone density.The case was completed with this device with no patient harm or delays.The sales rep was unable to provide a lot number.The device was discarded in the sharps container by the customer.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint #pc-(b)(4).Investigation summary: the complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes 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.Udi: (b)(4).-incomplete the lot number was not provided.

• Brand Name: GRYPHON HARD BONE DRILL
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7935284
• Report Number: 1221934-2018-54807
• Device Sequence Number: 288840
• Product Code: HWE
• UDI-Device Identifier: 10886705025527
• UDI-Public: 10886705025527
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 211601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1