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

Catalog Number	211042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The lot number is currently unavailable.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 bicep repair procedure the customer's lupine spiral fluted drill bit tip broke off inside the patient.The sales rep did not know how the device broke, and stated that the tip of the device was successfully removed, but did not know how it was removed.The sales rep did not know the bone quality of the patient.The case was completed with another drill bit with no patient harm or delay.The sales rep stated that there is no need for future surgical intervention.The sales rep was not present and could not provide any additional information.The sales rep could not provide a lot number for the device.The availability of the device is unknown.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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.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).The lot number is unknown.
Event or Problem Description
Additional information received on 01/23/2019 stating device would not returning for evaluation.

• 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: 8301440
• Report Number: 1221934-2019-56311
• Device Sequence Number: 13468326
• Product Code: HTW
• UDI-Device Identifier: 10886705001545
• UDI-Public: 10886705001545
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/14/2019

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: 01/14/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1