MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE; RONGEURS/KERRISONS/IVDS

Catalog Number RN4853 / 130814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

The two devices, manufactured respectively on 01/28/2015 and 05/22/2015, were returned and evaluated.No failure was detected, device performance conforms to specifications.Device history records complete and conforming to specifications.Routine final inspection of devices includes 100% testing of cutting function.Complaint not confirmed.Device not returned to manufacturer.

Event Description

The doctor was performing a microsurgical discectomy and was biting soft tissue with the device.Device does not cut.No harm done but the case took longer due to tearing of the tissue as opposed to cutting.

• Brand Name: RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE
• Type of Device: RONGEURS/KERRISONS/IVDS
• 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: 5472567
• MDR Text Key: 39423507
• Report Number: 8010386-2016-00005
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RN4853 / 130814
• Device Lot Number: 100180-1501, 100180-1505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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
• Patient Age: 56 YR