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	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.Investigation summary: the complaint device was not returned, it was discarded by the customer and thus not available for physical evaluation.Hence, the reported complaint cannot be confirmed.No further information regarding this event has been provided to determine a root cause for this failure.If additional information is made available, the investigation will be updated as applicable.Furthermore, no lot number or serial 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.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.Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
The sales rep reported via phone that the customer's lupine spiral fluted drill bit was dull during a shoulder repair.The case was completed with the device.There were no patient consequences or delays.The device is being returned.Update received from the sales rep on 1-8-2018: the device is not going to be returned, it was discarded.

• 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: 7556417
• Report Number: 1221934-2018-51086
• Device Sequence Number: 16612280
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1