MAUDE Adverse Event Report: SYNTHES BETTLACH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM; BONE PLATE

Catalog Number 04.503.638.01S

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not provided by reporter.Unknown when device malfunctioned.Not explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.Device history records was conducted.The report indicates that the: (b)(4)/ lot 9369363, manufacturing location: (b)(4), manufacturing date: 18th february 2015, expiry date: 1st february 2025.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 Description

It was found on (b)(6) 2015 that locking screws implanted in the patient's mandible have been loosened.The patient had the initial surgery on (b)(6) 2015.This report is 4 of 9 for (b)(4).

Manufacturer Narrative

(b)(4).(b)(6).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.

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Product investigation summary: the following devices were received for evaluation: part 04.503.638.01s / lots 9273378, 9369363, 9213139, 9273378, 9273378 (x5), part 04.503.640.01s / lot 9213139, 9257974 (x2), part 04.503.642.01s / lot 9219272 (x1), part 04.503.644.01s / lot 9279387 (x1).The shaft and head threads as well as the recess and tip sections show slight marks of use.Based on the surgical technique, the device specific adverse events of loosening, bending, or breakage of the device can occur.The exact cause for the loosening of the screws could not be determined.It is likely that bone movement and/or insufficient tightening of the screws in the plate led to loosening.No manufacturing-related failures were detected.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

Update: the complainant part was returned, indicating that a revision procedure was performed.No additional information was provided regarding this information.

• Brand Name: 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM
• Type of Device: BONE PLATE
• 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: 5228237
• MDR Text Key: 31316786
• Report Number: 9612488-2015-10572
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.638.01S
• Device Lot Number: 9369363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/17/2015; 01/15/2016; 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention