MAUDE Adverse Event Report: SYNTHES BETTLACH 6.0MM CARBIDE DRILL BIT STERILE; BIT,DRILL

Catalog Number 309.006S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 05/21/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a surgeon was performing a revision surgery of a plate system, for an unknown reason and was unable to remove the screws due to damaged screw recess.The surgeon first attempted to use extraction screws, but was not successful.It was reported an extraction screw broke due to strong resistance, reported to be like a cold welding condition.Then a carbide drill bit was used, but the broken extract screw was not able to be removed.The surgeon decided to leave the plate and screw in the patient and closed the operation.It was reported this resulted in a surgical delay of 120 minutes.This is report 1 of 6 for (b)(4).

Manufacturer Narrative

Additional common device name; hwe.Device is an instrument and is not implanted/explanted.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: our visual inspection has shown that the tip of the drill bit is blunt and worn out.These drill bits are single use devices and it is likely that the tip got blunt due to normal wear and tear.Lot 7728655 was manufactured in january 2011 to specification.No product fault could be found.Device was 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.

• Brand Name: 6.0MM CARBIDE DRILL BIT STERILE
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3884335
• MDR Text Key: 4546831
• Report Number: 9612488-2014-10235
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 309.006S
• Device Lot Number: 7728655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2012
• 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