MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-STANDARD FOR MATRIX; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.632.001

Device Problems Bent (1059); Material Distortion (2977)

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

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system device history records was conducted.The report indicates that the: manufacturing location: supplier (b)(4) purchased order no: (b)(4) were issued on 21-nov-2011.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 reported that a surgery for lumber stenosis took place on (b)(6) 2016.The surgeon used 4 screws in this surgery.When the surgeon was inserting the 3rd screw with the sleeve, he found that the sleeve grasped the screw at an angle a little, so he re-attached the sleeve and the screw properly.At that time, the sleeve and the screw created burrs and were damaged.No surgical delay was reported.No patient harm was reported.Broken pieces dropped into the patient's body once; however, all of the pieces were completely removed from the patient.The surgical procedure was successfully finished up.This complaint involves 2 parts this report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: both parts were manufactured according to the specification.Visual inspection shows that the threaded tip of the sleeve as well as the proximal part of the screw are partially broken off.Such breakages can occur due to mechanical overloading when lateral applied force is applied.Using the sleeve for positioning / correction in slanting direction may cause too high force on the connecting area what finally caused the breakage.Therefore we classify this breakage as caused by to high mechanical force during insertion.No product fault could be detected.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.

• Brand Name: HOLDING SLEEVE-STANDARD FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5672950
• MDR Text Key: 45701260
• Report Number: 1719045-2016-10428
• Device Sequence Number: 1
• Product Code: LXH
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.632.001
• Device Lot Number: 6705460
• Other Device ID Number: (01)07611819378056(10)6705460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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