MAUDE Adverse Event Report: RAIMUND WENZLER GMBH FS KERRISON RONGEUR

Catalog Number NL4273-83 / RW 5834 AU C

Event Type  malfunction  

Manufacturer Narrative

Evidence of extensive reuse of device.Device subject to unauthorized disassembly and modification, possibly weakening spring and leading to fracture of part.Hardness of fractured material tested and found conforming to specs.Device history record found conforming.Harm to patient not possible, since handle part of device outside surgical field during clinical use.Breakage of spring during surgery would affect ease of use by surgeon, not device function itself.Should more information become available, a supplemental report will be filed.

Event Description

The instrument was being used when a spring broke in the handle.No harm nor impact to patient.

• Brand Name: FS KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer (Section G): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer Contact: martin wenzler ; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582 ; 4249582738
• MDR Report Key: 5767940
• MDR Text Key: 48712889
• Report Number: 9611616-2016-00004
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: NL4273-83 / RW 5834 AU C
• Device Lot Number: 27103349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2010
• 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