MAUDE Adverse Event Report: SYNTHES BETTLACH TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR

Catalog Number 03.802.431

Device Problem Difficult To Position (1467)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that eleven devices were damaged due to normal wear and tear.Eight tapered u-joint drivers for synfix mini-open (03.802.431) are "floppy", saggy, and hard to aim.Two holding sleeves-standard for matrix have stripped out threading.One straight tip t25 driver-long is stripped.The events are not related to any specific case or patient.The devices will be returned for evaluation.This is report 3 of 11 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Manufacturer Narrative

No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development evaluation was completed: six tapered u-joint drivers for synfix (part 03.802.431, lot 2813613 manufactured january 2012, 7771071 manufactured march 2012, 8626490 manufactured october 2013 (x2), and 8104858 manufactured october 2012(x2)) were returned with the complaint of ¿floppy¿ and hard to aim.All six of these devices were tested and found to have lost their angular memory; the complaint for these drivers was confirmed.The applicable and associated drawings were reviewed.These drawings detail the appropriate dimensions, materials (custom 465 stainless steel and peek), and finishing processes for an angled t15 driver with a u-joint with position memory.The primary purpose of the u-joint mechanism on these instruments is to allow for the transmission of torque to the instrument's working end (driver) to divergent angles the access exposure would otherwise not accommodate for a straight instrument.The u-joint has a minimum of.026mm diametrical interference between the pin and peek bushing to create this position memory.The peek bushing provided positional retention, excessive torsional force may permanently deform it affecting the retention feature however the design is adequate for the application with the use of the guiding forceps, as specified in the technique guide.After reviewing the related product drawings, complaint history and risk analysis, the design was found to be adequate for its intended use and did not contribute to this complaint condition.This complaint is confirmed.The angular stability (memory) has been lost to some degree at the u-joint.This observation is consistent with an extreme bearing load applied which may reduce the memory capability of the u-joint.Extreme torque may cause deformations to the peek bushings however the design allows interference to create u-joint position memory and it is found adequate for the application with the use of the guiding forceps, as specified in the technique guide.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.

Event Description

The synfix mini-open had lost their ability to hold desired angles, rendering them "floppy".

• Brand Name: TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3754056
• MDR Text Key: 16596027
• Report Number: 2520274-2014-10790
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.802.431
• Device Lot Number: 8626490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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