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

Catalog Number 03.802.431

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a routine inspection of instruments prior to a surgical procedure, it was discovered that two (2) newer u-joint drivers were not holding (were loose).The instruments were reportedly not as rigid as the older models.This complaint is not related to a surgical case or a specific patient this report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis the following narrative and codes were corrected for clarity of the previously reported product development investigation results: the subject device (part number 03.802.431, tapered u-joint driver for synfix, lot number 9353046) was received for the complaint ¿will not hold as a result of a loose angle retention mechanism.¿ the subject device was manufactured mar 12, 2015 and has been used in the field for five months.The tapered u-joint driver for synfix (03.802.431) is a component of the synfix-lr system which is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (ddd) (synfix-lr system technique guide).The u-joint driver is specifically designed to insert 15-30mm synfix locking screws.The u-joint mechanism is designed to allow the transmission of torque to the tip at angles not achievable by a straight driver.The associated drawings were reviewed.These drawings detail the appropriate dimensions, materials (custom (b)(4) 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 ((b)(4)) and peek bushing ((b)(4)) 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.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The subject device was evaluated and was found to function as intended.The complaint condition is unconfirmed.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: subject device has been received and investigation summary performed, the investigation of the complaint articles has shown that: two tapered u-joint drivers for synfix (part# 03.802.431, lots 9353046 and 2525652) were received with a complaint of will not hold as a result of a loose angle retention mechanism.The instruments were manufactured 3/2015 and 10/2009 and have been in the field for 5 months and 6 years respectively.After evaluation the complaint condition was confirmed for lot 2525652, while lot 9353046 functions as intended.This investigation summary was approve.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: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT LUMBAR
• 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: 5013954
• MDR Text Key: 23427844
• Report Number: 9612488-2015-10422
• 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
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• 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: 9353046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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