MAUDE Adverse Event Report: SYNTHES SELZACH 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 317.260

Device Problem Break (1069)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a drill bit breakage occurred of the air pen drive engine.After breakage detection, it was not detected any fragment inside of the patient and also not observed fragments outside.The breakage did not interfere with surgery; the drill was replaced and the procedure was continued.There was no patient harm reported.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: 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 tip of the drill bit was broken.The investigation was not able to determine the exact cause which has led to this occurrence.The complaint condition is likely the result of too much mechanical force had been applied during the surgery, the device is a very delicate drill bit which requires extra caution during use.No product fault could be detected.The measurable dimensions of the broken drill bit was checked as far as possible and found to be in compliance with the technical drawings and ao/asif specification.The awareness date was incorrectly reported on the initial report as (b)(4) 2014.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional product codes: erl, hbe.Device is an instrument and is not implanted/explanted.Investigation could not be completed, no conclusion could be drawn as no device was returned.Review of manufacturing records has been requested.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: 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• 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: 4238815
• MDR Text Key: 5016267
• Report Number: 3000270450-2014-10142
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.260
• Device Lot Number: F-14329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2011
• 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
• Patient Age: 35 YR
• Patient Weight: 55