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

Catalog Number 03.802.431

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: a tapered u-joint driver for synfix (03.802.431 lot 2541692) was received with loose u-joint.The instrument is unable to hold angular stability (memory).The applicable and associated drawing and bushing 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 is adequate for its intended use and did not contribute to this complaint condition.The product did fail, so the complaint is confirmed.The angular stability (memory) has been lost to some degree at the u-joint.Although it is not clear how these instruments have been used, 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.The device is therefore determined to be suitable for its intended use.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

It was reported that during routine maintenance it was discovered the tapered u-joint driver has a u-joint that is loose and it will not hold the angle for screw insertion.There was no report patient or procedure involvement associated with this complaint.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No non-conformance reports 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.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: TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• 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: 3857047
• MDR Text Key: 12192255
• Report Number: 9612488-2014-10208
• 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: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• 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: 2684515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2011
• 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