MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR 8 INCHES 2MM BITE

Catalog Number NL4251-82T / 0120814BT

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.Since the lot number has not been provided by the user, it has not been possible to review the device history record.Since the device is not available for testing and evaluation, it has not been possible to confirm the reported problem nor to establish its cause.A review of complaints for the period 2014-2017 revealed that all complaints received with regard to similar failures were due to misuse by the user.Device not returned by user.

Event Description

During a laminectomy with posterolateral fusion the tip of a gold #2 kerrison rongeur broke off.The broken tip was retrieved intact by the surgeon.No further information available.

Manufacturer Narrative

The device was manufactured in 2010 and subject to extensive reuse, clearly exceeding the expected lifetime of 3 years.Review of manufacturing and quality control records revealed no issues.Hardness testing results were within specifications.The cutting edges of the instrument were worn (blunt) and increased effort would have been required for clinical use, possibly leading to fracture of the cutting edge.

• Brand Name: T-COAT MICRO HDL KERRISON RONGEUR 8 INCHES 2MM BITE
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer (Section G): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: markus pauli ; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604 ; 4619668540
• MDR Report Key: 6636074
• MDR Text Key: 77556253
• Report Number: 8010386-2017-00002
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

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: NL4251-82T / 0120814BT
• Device Lot Number: KF41
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1