MAUDE Adverse Event Report: SYNTHES TUTTLINGEN BONE RONGEUR SIDE-BITING 11MM HEIGHT

Catalog Number 03.808.023

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that during a maintenance check of the field equipment, it was discovered that the tip of the bone rongeur side-biting is broken.There was no patient or case involvement.There were no reported issues with the instrument prior to the discovery.This is reported 1 of 1 for (b)(4).

Manufacturer Narrative

Event date: unknown.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.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.The raw material is corresponding to the specifications.The hardness was measured at the time of the manufacturing and was found to be good.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

Device was used for treatment, not diagnosis.Additional narrative: the visual inspection of the returned device performed as part of the product investigation reported the distal tip of the lower jaw is cracked at the posterior point with the least material, the balance of the device is in good working condition.The bone rongeur, side-biting belongs to the luminary alif system and is used to remove disc material and cartilaginous tissue from vertebral endplates, cleaning the superior and inferior surfaces simultaneously.The technique guide for the system was reviewed ((b)(4)) for the proper use of this device.One bone rongeur, side-biting, 11mm height (part#03.808.023, lot# a7pa11, mfg mar2006) were returned with the complaint that ¿it was discovered that the tip of the bone rongeur side-biting (03.808.023) is broken.¿ upon receipt of this device it was seen that the distal tip of the lower jaw is cracked at the posterior point with the least material, the balance of the device is in good working condition.This complaint is confirmed.The associated drawings for this part were reviewed ((b)(4)) and the design, material (420a), and finishing processes were found to be adequate for the intended use of this device.Given the age of this device, and the location of the fracture, it is plausible that this complaint condition occurred as a result of use over time, it is possible that this device came into contact with material with a hardness greater than the cartilaginous tissue it is designated for use with.This complaint is confirmed, while it is unknown what ultimately caused this failure it is probable that this device came into contact with material with a hardness greater than the cartilaginous tissue it is designated for use with.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BONE RONGEUR SIDE-BITING 11MM HEIGHT
• 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: 4266472
• MDR Text Key: 5228285
• Report Number: 9680938-2014-10090
• 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
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.808.023
• Device Lot Number: A7PA11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2006
• 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