MAUDE Adverse Event Report: SYNTHES SELZACH 6.0MM TI CANNULATED MATRIX SCREW 45MM THREAD LENGT; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.616.645S

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.Additional narrative: no patient involvement reported.Additional product code for this report includes: mnh, mni, kwq, kwp.(b)(4).Device: 6.0mm ti cannulated matrix screw, not implanted or 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: please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4).Supplier: (b)(4), manufacturing date: 25 august 2014 expiry, date: 01 august 2024.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.Non-sterile 04.616.645 / 7747196 were manufactured in us, (b)(4).Dhr review: (b)(4) - date manufactured: 22-jul-2014, review of the dhrs showed there were no issues during the manufacture 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 were 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 1 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: 6.0MM TI CANNULATED MATRIX SCREW 45MM THREAD LENGT
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5673134
• MDR Text Key: 45703447
• Report Number: 3000270450-2016-10124
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• 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: 04.616.645S
• Device Lot Number: 9113651
• 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: 08/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1