MAUDE Adverse Event Report: SYNTHES SELZACH 1.1MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 317.220S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: erl, hbe.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 18.Nov.2016 expiry date: 01.Nov.2026.No 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.Non-sterile 317.220 / f-17998 was manufactured in (b)(4), manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 23.Dec.2015.No 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.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 europe reports an event in the (b)(6) as follows: it was reported the drill bit snapped and broke during an unknown surgical procedure on (b)(6) 2017, resulting in additional case time and extra exposure from x-ray to retrieve the broken fragments.Surgery was completed successfully with a delay of approximately 40 minutes, all fragments were retrieved.Facility reported an additional occurrence of a broken drill bit.This report addresses the event on (b)(6) 2017.The additional event is addressed in (b)(4).Concomitant device reported: drill (part number unknown, lot number unknown, quantity 1).This report is for one (1) 1.1mm drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 1.1MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6697565
• MDR Text Key: 80039656
• Report Number: 3000270450-2017-10235
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.220S
• Device Lot Number: L200942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1