MAUDE Adverse Event Report: SYNTHES BETTLACH 2.5MM HIGH SPEED DRILL BIT STERILE; BIT,DRILL

Catalog Number 309.503S

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the extract surgery took place for distal tibia, implanted in 2013.The reported screw, which inserted at the most distal part, could not come off during the surgery.Although the surgeon attempted to extracted the screw used by the drill bit, the screw was unable to be removed.Eventually he wrecked the head of the reported screw by the carbide drill bit of, and completed the surgery.It was also reported that no remain of the screw was confirmed as the surgeon succeeded to take off the shaft of the screw.The surgery was extended for 30 minutes due to this event.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information reported.Explant date: exact implant date unknown.An investigation summary was performed.The investigation of the complaint articles could not be performed, no conclusion could be drawn, as no product was returned.Device history records was conducted: manufacturing location, bettlach, manufacturing date: 22nd december 2012, expiry date: 1st december 2021.Review of the device history record (s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.5MM HIGH SPEED 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: 4789465
• MDR Text Key: 5877079
• Report Number: 9612488-2015-10280
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 309.503S
• Device Lot Number: 2822534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2011
• 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