MAUDE Adverse Event Report: SYNTHES SELZACH DRILL BIT Ø3.2 CALIBR L270.5 3FLUTE F/TI; BIT, DRILL

Catalog Number 356.220

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: the devices were discovered broken on (b)(6) 2017; it is unknown when they broke.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial contact phone number: (b)(6).Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: (b)(4).Supplier: external supplier (b)(4).Manufacturing date: june 06, 2011.No non-conformance reports 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.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: it was reported that when the loan set was checked it was found that the drills are broken.It was noted there was no patient involvement.When the device was received by the manufacturer it was noted that the drill bit is not broken; the instrument was re-sharpened several times.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The report indicates that the: article 356.220 lot f-11559; the visual inspection of the returned drill bit has shown scratches on the coupling.The cutting part of the drill bit is shorter as usual and approximately 12mm of the cutting edges are missing.Further investigation has shown that this instrument was manufactured in june 2011.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.As the cutting tip and edges are still available but approximately 12mm are missing we can assume that the part was re-sharpened several times.Device 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: DRILL BIT Ø3.2 CALIBR L270.5 3FLUTE F/TI
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6731527
• MDR Text Key: 80801672
• Report Number: 3000270450-2017-10245
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819800502
• UDI-Public: (01)07611819800502(10)F-11559
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.220
• Device Lot Number: F-11559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2011
• 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