MAUDE Adverse Event Report: SYNTHES BETTLACH DEPTH GAUGE FOR MINI SCREWS; GAUGE, DEPTH

Catalog Number 319.11

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Subject device has been received and a service and repair evaluation were performed.The investigation of the complaint articles has shown that: the customer reported the tip of the depth gauge was broken.The repair technician reported tip broken as the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on (b)(6) 2016 that during an intraoperative procedure, the depth gauge for mini screws tip is broken.There was no negative impact to patient and no surgical delay.This complaint involves 1 device this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was attempted for the subject device lot.The subject device is older than 20 years.At this time standard operating procedures for manufacturing document retention required that records be stored for 10 years after date of manufacture.This procedure was in place until (b)(6) 2014.Results from additional investigation being performed by synthes customer quality are pending completion.Date returned to manufacturer was aug 26, 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPTH GAUGE FOR MINI SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5930775
• MDR Text Key: 54028801
• Report Number: 9612488-2016-10365
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.11
• Device Lot Number: 2012
• Other Device ID Number: (01) 10886982190024(10) 2012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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