MAUDE Adverse Event Report: SYNTHES BETTLACH 10.5MM CANNULATED DRILL BIT; BIT, DRILL

Catalog Number 03.224.003

Device Problem Break (1069)

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

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).Manufacturing location: (b)(4).Manufacturing date: april 23, 2013.No deviation or non-conformance reports were marked in the device history record.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(4)reports an event in (b)(6) as follows: during a locking compression plate - dynamic hip screw system (lcp-dhs) operation on (b)(6) 2016, the tip of the drill bit broke when the surgeon brought the drill bit along the wire in contact with external cortical bone and started to drill.The drill bit broke before the external cortical bone was shaved so there was no body residue.There was no surgical delay.The drill was damaged before the external cortical bone was ground, so there was no fragment remained in the body.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing investigation was performed on the subject device (10.5mm cannulated drill bit, part # 03.224.003, lot # 8275357).The product was returned in a packaging different from the original packaging.The laser marking was readable.The cutting edge from the drill bit is broken.The cutting edge shows scratches and the drill bit has damages.All dimensions relevant for the function and the hardness of the product were measured, and fulfill the specifications.The lot of the raw material of article 03.224.003 is not tracked by number.Therefore the check was done based on fifo (first in/first out) by investigation of the raw material order, which were closest to the start of the manufacturing order of the component.It was found that the used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed but not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.No indication for product related issue was 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: 10.5MM CANNULATED DRILL BIT
• Type of Device: BIT, DRILL
• 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: 6101033
• MDR Text Key: 59854330
• Report Number: 9612488-2016-10461
• Device Sequence Number: 1
• Product Code: HTW
• 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: 10/21/2016

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: 03.224.003
• Device Lot Number: 8275357
• Other Device ID Number: (01)07611819193451(10)8275357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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 Age: 82 YR