MAUDE Adverse Event Report: SYNTHES TUTTLINGEN DISC RONGEUR STRAIGHT/4MM WIDTH

Catalog Number 389.45

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/29/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The device history record review could not be performed as the records could not be identified.The device is over 12 years old.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.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 screw that attaches the handle to the upper arm of the disc rongeur fell out at the back table.This was noted during an l5-s1 anterior lumbar interbody fusion (alif) procedure.Reportedly, the screw was discarded and the instrument was set aside and not used.The surgeon used another similar/like instrument and completed the case.There was no delay to the surgery.The patient outcome was reportedly stable following the procedure.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing investigation was conducted.The report indicates that the manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.This device is nearly 12 years old.It cannot be determined as the screw was not received that a full investigation could be performed.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: DISC RONGEUR STRAIGHT/4MM WIDTH
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4121970
• MDR Text Key: 12400251
• Report Number: 9680938-2014-10068
• Device Sequence Number: 1
• Product Code: HTX
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 389.45
• Device Lot Number: A7LA13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2002
• 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: 58 YR