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

Catalog Number	211033
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and evaluated.The drill bit is broken just after the flats on the proximal end at the weld site, confirming this complaint.From visual observation the drill appears to have seen very heavy use.The etching is faded and there are numerous scratches up the shaft.The root cause of this complaint is a side load placed on the drill while drilling in combination with heavy use of the device.A batch review was not done as the batch information was not provided.At this point in time, no corrective action is required, and no further action is warranted.However, depuy 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.This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
During a shoulder repair, the drill bit snapped during use on patient.Nothing fell into patient.Surgeon just carried on with the procedure deciding not to go for the 3rd anchor as 2 anchors were enough.Case completed successfully with no delay.There was no adverse event to the patient.

• Brand Name: LUPINE STABILIZATION DRILL BIT
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7759137
• Report Number: 1221934-2018-53501
• Device Sequence Number: 13879569
• Product Code: HTW
• UDI-Device Identifier: 10886705001453
• UDI-Public: 10886705001453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2015

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: 211033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2015
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1