MAUDE Adverse Event Report: SYNTHES SELZACH 1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.076

Device Problem Break (1069)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted or explanted.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(6) - manufacturing date: january 7, 2010.A review of the delivery order showed that no deviations or non-conformance reports were documented for this article.(b)(6) pieces were manufactured for this article/lot combination.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a craniotomy was performed on (b)(6) 2016 during which the surgeon attempted to fix the patient's bone flap in order to close the cranium.The surgeon intended to insert a 4mm matrixneuro screw, but the tip was dull, which prevented insertion into the cranial bone.A spare screw was available for use.The procedure was completed successfully with a three (3) minute surgical delay.On (b)(6) 2016, the manufacturer received a broken 1.5mm drill bit labelled with complaint number (b)(4).At this time, it is presumed that the device was used and broken during the procedure mentioned above.Details pertaining to the circumstances surrounding the breakage are unknown.Further, no information was provided about additional surgical intervention that may have been required.Concomitant device(s) reported: screwdriver (part/lot: unknown / quantity: (b)(4)).Both the screw and the drill bit were assessed for reportability; it was determined that only the broken drill bit represented a reportable incident.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The received part was added to this complaint in error.The event associated with this drill bit has been captured in and reported under its own complaint file with identification number (b)(4).Any additional information and all investigative results will be reported under mfr-3000270450-2016-10165.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.

Event Description

The received part was added to this complaint in error.The event associated with this drill bit has been captured in and reported under its own complaint file with identification number (b)(4).Any additional information and all investigative results will be reported under mfr-3000270450-2016-10165.

• Brand Name: 1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL
• Type of Device: DRILL, BONE, POWERED
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5819111
• MDR Text Key: 50392817
• Report Number: 3000270450-2016-10177
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082649
• 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: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.076
• Device Lot Number: F-10057
• Other Device ID Number: (01)10887587013626(10)F-10057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2010
• 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