MAUDE Adverse Event Report: SYNTHES SELZACH DRILL BIT Ø1.5 L67/55 2FLUTE; BIT, DRILL

Catalog Number 513.090

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported two drill bits were received from the same part family band had different color markings.The reported indicated one bit had red markings and the other bit had blue markings.No patient was involved.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The visual inspection of the returned device performed as part of the manufacturing investigation reported the color coding of this article is red.The item was in the original package.Both articles (lot no f-14878 and lot no f-15727) were manufactured from the drawing (b)(4) index a and are made according to the specifications at the time of manufacturing if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø1.5 L67/55 2FLUTE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4042402
• MDR Text Key: 4904867
• Report Number: 3000270450-2014-10091
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2014

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: 513.090
• Device Lot Number: F-15727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 08/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1