MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a drill bit clashed with the nail during the locking step of an expert nail procedure on (b)(6) 2015.The surgeon reportedly had to manually insert the distal nail blocks and use strength to lock the nail holes.A forty-five (45) minute surgical delay was noted.This report is for one (1) unknown drill bit.(b)(4).

Manufacturer Narrative

Patient initials are (b)(6).This report is for one (1) unknown drill bit.Device is an instrument and is not implanted or explanted.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4942899
• MDR Text Key: 17940220
• Report Number: 2520274-2015-15024
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR