MAUDE Adverse Event Report: SYNTHES BETTLACH 2.5MM DRILL BIT/QC/GOLD/110MM; N/A

Catalog Number 310.250

Device Problem Dull, Blunt (2407)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product codes: gff, gfa, hs.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: dhr review for: part: 310.250 2523753, manufacturing location: (b)(4), manufacturing date: 08.Sep.2009.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the complained drill bit was used in surgery for the radioulnar bone diaphysis fracture on (b)(6) 2016.With the drill bit fixed on a drill, the surgeon tried to make a lower hole.But he noticed the drill bit was clearly dull.So he could not complete the drilling work.Not even one hole was made.The surgery was extended for fifteen minutes.As an alternative procedure, he made a hole with 2.4mm k-wires owned by the hospital.Finally, screws were inserted after taping.Complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (2.5mm drill bit/qc/gold/110mm), part number 310.250, lot number 2523753.The subject device was returned with the complaint condition stating that upon visual inspection of the complaint device it can be seen that tip is badly worn down (dull), this thus confirming the complaint description.Moreover a review of complaints data base shows, that there are no other complaints for this issue from this article and lot number.The exact reason for this occurrence was not able to be determined, but during the operation an application error may have taken place and/or that wear and tear from often use over the years (as the instrument is over 7 years old), led to this damage.To prevent malfunctions, it is necessary worn or damaged instruments to replace and/or to operate according to the instruction for use ¿ synthes cutting tools.It was concluded that 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: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: N/A
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6090570
• MDR Text Key: 59574816
• Report Number: 9612488-2016-10456
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/17/2016

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: 310.250
• Device Lot Number: 2523753
• Other Device ID Number: (01)07611819018631(10)2523753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2009
• 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