MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET CC STEP DRILL 3.2MM; SURGICAL HAND DRILL

Catalog Number	285240
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/02/2018
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.(b)(4).The lot number is currently unavailable.
Event or Problem Description
Latarjet; xxxx xxx, (b)(6) hospital (b)(6) 2018.During use it was noted that the coracoid drill was blunt and the solid screwdriver was rounded.Surgeon used the blunt & rounded instruments, 2-3 minute delay to procedure.
Additional Manufacturer Narrative
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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: the manufacturer contact name has been updated as (b)(4).Contact phone number and email address have been updated accordingly.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  further, no lot numbers were supplied which precludes conducting a 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.

• Brand Name: LATARJET CC STEP DRILL 3.2MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7731177
• Report Number: 1221934-2018-54240
• Device Sequence Number: 13804287
• Product Code: LXH
• UDI-Device Identifier: 10886705017942
• UDI-Public: 10886705017942
• 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,Followup
• Report Date (Section B): 07/02/2018

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: 285240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 12/13/2018
• Patient Sequence Number: 1