MAUDE Adverse Event Report: SYNTHES TUTTLINGEN DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM

Catalog Number 03.605.002

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review will be requested.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 two broken disc rongeur instruments were to have broken tips after central sterile processing on an unknown date.One of the instruments was reportedly dropped during sterile processing which resulted in the breakage.The instruments were part of the field equipment, oracle spacer system set.The tips of the broken instruments were not found.There was no reported patient or surgical involvement.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Manufacturing date: march 02, 2012.Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.All parts were checked for function at the final inspection.The raw material for the whole instrument is corresponding to the specifications.No non-conformance reports were generated during production.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

A product investigation was completed: one 4mm disc rongeur and one 6mm disc rongeur was received with a complaint stating that the instruments were found broken at the tip postoperatively.Upon evaluation of the returned items, it was noted that the moving cup jaw was sheared off at the hinge.The complaint is confirmed.Pert he technique guide, the disc rongeurs are a discectomy instrument that is part of the proprep disc preparation set and is also available in the oracle spacer system.Disc rongeurs are general surgical instruments used to remove disc and tissue in small spaces and are available in 4mm and 6mm jaw widths.Relevant drawings for the returned devices were reviewed.The design and materials were found to be appropriate for the intended use of these devices.Device history reviews showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.It is likely that excessive force or improper handling contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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: DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5418030
• MDR Text Key: 37719933
• Report Number: 9680938-2016-10019
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.002
• Device Lot Number: T976720
• Other Device ID Number: (01)10705034712345(10)T976720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2012
• 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