MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Catalog Number 309.600

Device Problem Break (1069)

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device not implanted/explanted: fragments retained in patient.(b)(6).(b)(4).This event resulted in a retained fragment, and caused a thirty minute surgical delay.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the drill bit tip broke in patient and the surgeon was unable to retrieve the broken off piece.The surgery was prolonged about 30mins.Patient outcome is ok.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5584511
• MDR Text Key: 42890959
• Report Number: 2520274-2016-12117
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• 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