MAUDE Adverse Event Report: SYNTHES BETTLACH MATRIXMANDIBLE DEPTH GAUGE; GAUGE, DEPTH

Catalog Number 03.503.036

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: february 28, 2011.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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

It was reported that a matrixmandible depth gauge was sticking and not gliding smoothly on the knob.There was no patient or surgical involvement.The issue was discovered upon routine inspection of the equipment.No additional information is available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product investigation was performed for the subject device (part number 03.503.036, matrixmandible depth gauge, lot number 2702854).The subject device was received undamaged.The associated drawings for the subject device were reviewed and no drawing issues or discrepancies were noted.There was no observable damage or issues found with the device.The device actuates as designed without any issues and the distal hooked tip is undamaged and not bent.The complaint condition could not be replicated, and the cause of the complaint condition could not be determined.This complaint is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXMANDIBLE DEPTH GAUGE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5009722
• MDR Text Key: 23223377
• Report Number: 9612488-2015-10420
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.503.036
• Device Lot Number: 2702854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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