MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE SPIRAL FLUTED DRILL BIT; SURGICAL HAND DRILL

Catalog Number	211042
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
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 during a shoulder repair procedure the customer's lupine spiral fluted drill bit was dull the sales rep stated that it is dull as a result of use over time rather than becoming dull during this case.The sales rep stated the patient's bone quality was normal.The customer's lupine stabilization sawtooth drill guide tip was bent and led to difficulties moving the lupine drill bit through.The sales rep did not know how the device became bent.The case was completed with these devices with no patient harm or delays.The sales rep was unable to provide lot numbers for these devices.The devices were discarded 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 #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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).

• Brand Name: LUPINE SPIRAL FLUTED DRILL BIT
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7948779
• Report Number: 1221934-2018-54902
• Device Sequence Number: 19065001
• Product Code: HTW
• UDI-Device Identifier: 10886705001545
• UDI-Public: 10886705001545
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/03/2018

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: 211042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1