MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG KERRISON RONGEUR, LUMBAR, 40" UP, 4 MM, 8 INCHES 203 MM

Catalog Number 53-1417 / 0140814C

Device Problems Inadequate Service (1564); Misassembly by Users (3133)

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

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned without the screw and root cause of the failure could not be established.Traces of the original screw fixation mechanism were observed.It may be that the instrument was disassembled for cleaning despite ifu instructions for it not to be taken apart.Manufacturing and quality control records were reviewed and found to be conforming to specifications.Additional information has been requested on event and patient outcome.Should additional information become available, a follow-up report will be submitted.

Event Description

During surgery, the screw on the slide came out after several uses, falling into the patient.No additional details are available at this time.No harm to patient has been reported.

Manufacturer Narrative

This follow-up report is being submitted to provide fda additional data not available at time of submission of initial report, specifically: date of event, initial reporter, and adverse event report number of us importer.

• Brand Name: KERRISON RONGEUR, LUMBAR, 40" UP, 4 MM, 8 INCHES 203 MM
• 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
• MDR Report Key: 6787639
• MDR Text Key: 82985085
• Report Number: 8010386-2017-00003
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1417 / 0140814C
• Device Lot Number: M5546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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