MAUDE Adverse Event Report: SYNTHES SELZACH 5.0MM THREE-FLUTED DRILL BIT QC/356MM/126MM CALIBRATION; BIT,DRILL

Catalog Number 03.008.008

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review ¿ manufacturing location: (b)(4).Legal manufacturer: external supplier (b)(4).Manufacturing date: 17 feb 2011.No ncrs were generated during production.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.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.

Event Description

Device report from synthes eu reports an event in (b)(6) as follows: during surgery, two (2) 4.2 mm and two (2) 5 mm drill bits were used, however they were not sharp thus taking longer to drill through the bone.The surgery was reportedly extended for a few minutes.There is currently no additional information.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Initial reporter: hospital contact phone number ¿ (b)(6).Device investigation summary ¿ the drill bits were analyzed for conformance to print specifications as well as the device history records were reviewed; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question (manufactured in the year 2011).Further investigation has shown that the cutting edges have heavy traces of wear.Since no manufacturing related condition was found, it is likely that normal wear and tear during frequent use.It is noted; blunt drill bits require more mechanical power during the application, therefore it is recommend that blunt or damaged instruments need to be exchanged before surgery.No product fault could be detected.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: 5.0MM THREE-FLUTED DRILL BIT QC/356MM/126MM CALIBRATION
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5157401
• MDR Text Key: 28910254
• Report Number: 3000270450-2015-10212
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.008.008
• Device Lot Number: F-11563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2011
• 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