MAUDE Adverse Event Report: SYNTHES BETTLACH 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM; BIT,DRILL

Catalog Number 03.010.103

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.(b)(6).A device history record (dhr) review was performed for part # 03.010.103, lot # 8901258: manufacturing location: (b)(4), manufacturing date: 01.April 2014: no non-conformance reports (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.A product investigation was performed.We have received a drill bit (part # 03.010.103, lot # 8901258) for investigation.The visual inspection has shown that approximately 9 mm from the fluted tip section is broken off.The broken tip was not returned for evaluation.Additionally, it is clearly visible that the cutting edges are worn out and strongly damaged.There were no other damages or signs of misuse detected.The used material was stainless steel (b)(4) as required.The measurements of the hardness after the hardening procedure were within the required specification.Based on these findings we exclude any manufacturing related issue.Outer diameter of the device was measured per relevant drawing and was within the required specifications.Based on the provided information we are not able to determine the exact cause which has led to this breakage.We only can assume that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that upon receipt of the loan set it was identified that the first drill bit has traces of blows on the arm and the tip of the second drill bit is broken.No surgical delay or patient involvement reported.Upon manufacturer¿s investigation of the returned device it was identified that approximately 9 mm from the fluted tip section of the first drill bit is broken off.Additionally, it is clearly visible that the cutting edges are worn out and strongly damaged.This condition was re-evaluated and determined to be reportable on (b)(6) 2017.This report is for one (1) 3.2 mm three-fluted drill bit.This is report 2 of 2 for complaint com-(b)(4).

• Brand Name: 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
• 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: 6944083
• MDR Text Key: 90312125
• Report Number: 9612488-2017-10517
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775398
• UDI-Public: (01)07611819775398(10)8901258
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.103
• Device Lot Number: 8901258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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