MAUDE Adverse Event Report: SYNTHES TUTTLINGEN BONE RONGEUR SIDE-BITING 9MM HEIGHT

Catalog Number 03.808.022

Device Problem Break (1069)

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: 03.808.022, synthes lot number: t943457: release to warehouse date: feb 19, 2011.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 at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records, certification test values and acceptance criteria.All (b)(4) parts of the lot were checked 100% for critical features and for function at the final inspection.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 bone rongeur side-biting has a broken tip.This issue was discovered during a routine inspection of an evaluation set.No patient involvement.This is report number 1 of 2 for com-(b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device part (03.808.022 lot t943457- 9mm bone rongeur side-biting).The subject device was returned with a complaint stating that the rongeur has a broken tip.The complaint was able to be confirmed at customer quality as the distal tip of one of the jaws of the rongeur displayed a transverse fracture without a generated fragment.The cracking of the rongeur is likely due to wear over time and the device coming into contact with a material harder than cartilaginous tissue.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 03.808.022 bone rongeur is part of the luminary alif disc preparation instrument set (01.808.003).The instrument is used to remove disc material and cartilaginous tissue from the superior and inferior surfaces of the vertebral endplates.The associated drawings for this part were reviewed and the design, material, and finishing processes were found to be adequate for the intended use of this device.A device history review was performed for the returned instruments¿ lot number and no non conformance reports (ncr's) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Given the age of this device, and the location of the fracture, it is likely that this complaint condition occurred as a result of use over time.Additionally, it is possible that this device came into contact with material with hardness greater than the cartilaginous tissue it is designated for use with.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 the device coming into contact with material with harness greater than the intended cartilaginous tissue.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.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 9MM HEIGHT
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5939258
• MDR Text Key: 54312314
• Report Number: 9680938-2016-10140
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.808.022
• Device Lot Number: T943457
• Other Device ID Number: (01)10705034724157(10)T943457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/20/2016; 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2011
• 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