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

Catalog Number 03.802.431

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Part number: 03.802.431, synthes lot number: 9353046: release to warehouse date: mar 12, 2015.Mfg site: (b)(4).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.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 on (b)(6) 2016 that a tapered u-joint driver has a loose u-joint.This issue was discovered during a routine inspection of an evaluation set.No patient involvement.This is report number 2 of 2 for com-(b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device part (03.802.431 lot 9353046, tapered u-joint driver for synfix mini-open).The subject device was returned with a complaint stating that the screwdriver was loose.The complaint was able to be confirmed at customer quality as the universal joint of the driver was loose and unable to retain angulation.The u-joint has an interference fit between the pin (03_802_230_3) and peek bushing (03_802_230_2_2) to create this position memory.It is likely that excessive torsional force permanently deformed the bushing affecting its retention ability for the u-joint driver.A visual inspection, functional test, device history review (dhr), complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The tapered u-joint driver for synfix (03.802.431) is 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) (j7022-i).The instrument feature u-joint mechanisms to allow the transmission of torque to the tip at angles not achievable by straight instruments.The associated drawings for the returned instrument were reviewed.These drawings detail the appropriate dimensions, materials (custom 465 stainless steel and peek), and finishing processes for the device.The primary purpose of the u-joint mechanism on this instrument is to allow for the transmission of torque to the instruments' working end (driver/awl) to divergent angles which would be inaccessible by straight instruments.The u-joint has an interference fit between the pin (03_802_230_3) and peek bushing (03_802_230_2_2) to create this position memory.It is likely that excessive torsional force permanently deformed the bushing affecting its retention ability.The instrument is still usable if utilized with the guiding forceps as specified in the system technique guide.A device history review was performed for the returned instruments¿ lot number and no non conformance reports (ncrs) or complaint-related issues were identified with the lots number which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A definitive root cause was unable to be determined, although the failure mode is consistent with typical wear and tear experienced over the life of the product.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: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5939568
• MDR Text Key: 54776383
• Report Number: 9612488-2016-10369
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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
• Other Device ID Number: (01)10705034722436(10)9353046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• 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