MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL LATARJET CC STEP DRILL 3.2MM; SURGICAL HAND DRILL

Catalog Number	285240
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
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.(b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
Surgeon mentioned when he was using the coracoid step drill and that it was difficult to get through the bone - drill was very blunt and needs replacing.Also when using the cannulated screwdriver he mentioned it was rounded - appeared stripped and also needed replacing.
Additional Manufacturer Narrative
Product complaint # (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 is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a device history record (dhr) review.At this point, 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 not currently available.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

• Brand Name: LATARJET CC STEP DRILL 3.2MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7512498
• Report Number: 1221934-2018-50637
• Device Sequence Number: 1897716
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2018

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?: Yes
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/19/2018; 12/11/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 12/10/2018; 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1