MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER/RC DRBIT ARTHRO 2.9MM; SURGICAL HAND DRILL

Catalog Number	211513
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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 was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the drill bit was dull and could not go through the bone during use.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).The lot number is currently unavailable.Associated medwatch: [mr#1221934-2018-54510].
Event or Problem Description
It was reported via phone by the sales rep that two of his super/rc drill bits were dull and would not go through the bone during a shoulder procedure.The doctor used another 2.9 drill bit and was able to complete the procedure with no patient consequences or delays.The customer discarded both devices.

• Brand Name: SUPER/RC DRBIT ARTHRO 2.9MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7793313
• Report Number: 1221934-2018-54512
• Device Sequence Number: 1143894
• Product Code: GFG
• UDI-Device Identifier: 10886705001750
• UDI-Public: 10886705001750
• 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
• Report Date (Section B): 07/27/2018

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: 211513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1