MAUDE Adverse Event Report: SYNTHES HAGENDORF LONG SMALL HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number 388.31

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

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.Dhr review ¿ manufacturing site: (b)(4).Manufacturing date: february 18, 2014.No ncrs 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.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 the tip of a long, small hexagonal screwdriver broke off in the transconnector during a surgery to treat a l3 fracture using synthes uss.The screwdriver broke while tightening the transconnector set screw.The screwdriver fragment could not be removed from the transconnecter.The surgeon reportedly removed the transconnector and replaced it with a new one.There was a two (2) minute surgical delay.The procedure was successfully completed.No fragments were left in the patient.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number 388.31, lot number 8760156, long small hexagonal screwdriver).The subject device was returned with the complaint that the tip of the device broke off in the transconnector while tightening the transconnector set screw.The returned device is included in multiple spine sets including the universal spinal system (uss) technique guide and the click-x top loading system technique guide.The returned long small hexagonal screwdriver (388.31, 8760156) was received in decent condition, other than the tip of the screwdriver which enters the screw recess, which appeared to be cleanly sheared off.The tip of the screwdriver was found in the returned titanium low profile transconnector cap screw.The returned long small hexagonal screwdriver was manufactured on 18feb14 and the associated drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No ncrs were generated during production of the returned parts.Review of their device history records shows that there were no issues during the manufacture of the products that would contribute to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The provided complaint description does not include information which can help determine a definitive root cause for the complaint condition.Material 440a which makes up the shaft of the long small hexagonal screwdriver (388.31) is acceptable for the instrument¿s use as the driver can withstand torques up to 5.6nm compared to the 2.0nm torque needed to tighten the set screw.The cap screw of the returned transconnector is used to tighten its screw and engage with the stargrind in order to secure the desired angle.The unusual gouges seen on the underside of the returned transconnector near the set screws which are used to secure rods might be an indication that the subject procedure involved some unique circumstances which required the use of excess force and an unusual approach.It is possible that during the distraction/compression tightening process the tip of the returned screwdriver was exposed to unintended off-axis loads which could have contributed to the complaint condition, but a definitive root cause for the tip breakage cannot be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LONG SMALL HEXAGONAL SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5337875
• MDR Text Key: 34761864
• Report Number: 3003875359-2015-10571
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.31
• Device Lot Number: 8760156
• Other Device ID Number: (01)10705034772417(10)8760156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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
• Patient Age: 46 YR