MAUDE Adverse Event Report: SYNTHES BALSTHAL TI MULTI VECTOR DISTRACTOR ASSEMBLY/RIGHT WITH 35MM ARMS; SCREW FIXATION INTRAOSSEOUS

Catalog Number	487.966
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Unknown if device was implanted on (b)(6) 2017.Not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: manufacturing location: part: 487.966, lot: l179386, manufacturing location: (b)(4), manufacturing date: 24.Oct.2016.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes on an event in (b)(6) as follows: it was reported that the surgeon had difficulty to extend the reported device during a mandibular extension surgery on (b)(6) 2017.The surgeon confirmed the extension length indicator showed 1 mm.However, the extended actual measured length was 5 mm.The surgeon commented that the surgery was somehow completed.The customer understood how the device works and how to use it for the upcoming surgeries, so the device will not be returned for investigation.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

• Brand Name: TI MULTI VECTOR DISTRACTOR ASSEMBLY/RIGHT WITH 35MM ARMS
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• MDR Report Key: 6635690
• Report Number: 3009450863-2017-10016
• Device Sequence Number: 16146108
• Product Code: DZL
• UDI-Device Identifier: 10887587055848
• UDI-Public: (01)10887587055848(10)L179386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 487.966
• Device Lot Number: L179386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention