MAUDE Adverse Event Report: SYNTHES GMBH DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM WIDTH 330MM

Catalog Number 03.605.001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date during an unknown procedure, the tip of the disc rongeur broke.There is no further information available.This report is for one (1) disc rongeur straight without teeth 4mm width 330mm.This is report 1 of 1 for (b)(4).

Event Description

The surgery was completed using other devices.The broken instrument was not to be implanted and the fragment was easily removed.There were no consequences for the patient and a delay of about five (5) minutes.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part number: 03.605.001; lot number: t928326; manufacturing site: tuttlingen; release to warehouse date: 20-aug-2008.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 12 years old).Visual inspection: disc rongeur straight, 4mm x 330mm (part 03.605.001, lot t928326) was received at customer quality (cq).Upon visual inspection at cq.Visual inspections revealed that the tip of the device was found to be broken.Hence the complaint is confirmed.Does the received condition agree with the complaint description? yes.Was the complaint confirmed? yes.Dimension inspection: dimensional inspection cannot be performed due to post manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, due to the design of the device.Document/specification review: the following drawing, reflecting the manufactured and current revisions were reviewed.Disc rongeur straight.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 4MM WIDTH 330MM
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11688710
• MDR Text Key: 249256834
• Report Number: 8030965-2021-03038
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 07611819898936
• UDI-Public: (01)07611819898936
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.001
• Device Lot Number: T928326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1