MAUDE Adverse Event Report: SYNTHES USA DRILL BIT Ø1 L46/34 2FLUTE; BIT, DRILL

Catalog Number 513.005

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).This event resulted in a retained fragment, and in a 60 minute surgical delay, which prolonged the patient's exposure to anesthesia, and may lead to increased risk of infection.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 during surgery of a (b)(6) male patient, two drill bits were broken.The tips of the drill bits were left into the patient's bone, but the surgeon used other drill bits instead to resolve the problem.The surgery was prolonged about 60 minutes.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).

• Brand Name: DRILL BIT Ø1 L46/34 2FLUTE
• 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: 5508225
• MDR Text Key: 40601617
• Report Number: 2520274-2016-11713
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 513.005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• 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
• Patient Age: 32 YR