MAUDE Adverse Event Report: S.U.A. MARTIN GMBH & CO. KG T-COAT MCR HDL KRSN RONG, THIN; KERRISON RONGEUR

Catalog Number NL4258-83T / 2430814ABT

Device Problems Fracture (1260); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The rongeur was returned without the broken-off tip.Microscopic inspection of the device revealed evidence of repair and/or rework by unauthorized third parties.Notches and grinding marks on the cutting edge of the rongeur and marks on the screw indicate faulty repair work.Possibly the missing footplate was also subject to grinding, diminishing material stability and increasing the risk of breakage.Hardness of the returned device was tested and found to conform to specifications.Review of manufacturing documents show that the device conformed to specifications at the time of release.

Event Description

The tip of the instrument broke and was recovered during the procedure with no harm to patient.It was not necessary to extend the procedure.

• Brand Name: T-COAT MCR HDL KRSN RONG, THIN
• 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: 10703386
• MDR Text Key: 214804907
• Report Number: 8010386-2020-00001
• 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
• Report Date: 10/20/2020

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: Health Professional
• Device Catalogue Number: NL4258-83T / 2430814ABT
• Device Lot Number: MS49
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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