MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN FOOTPLATE

Catalog Number RD4824M

Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned incomplete (screw missing) and showed evidence of repeated repair work performed by unauthorized third parties.Device in use since 2005, well above its expected lifetime.

Event Description

In the middle of surgery it was discovered that the device was missing screw.The device was not in contact with patient.Patient not affected, no injury nor medical intervention required.No delay in surgery.

• Brand Name: RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN FOOTPLATE
• 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: 5982740
• MDR Text Key: 55787371
• Report Number: 8010386-2016-00008
• 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: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RD4824M
• Device Lot Number: 1140814BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2005
• 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