MAUDE Adverse Event Report: S.U.A. MARTIN GMBH & CO. KG T-COAT MICRO HDL KERR RONG THIN 8IN 2MM; KERRISON RONGEUR

Catalog Number NL4258-82T / 2420814ABT

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

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Microscopic inspection of the device revealed evidence of repair, and/or rework by unauthorized third parties.Notches and/or grinding marks on the cutting edge, the screws and the slider of the rongeur indicate faulty repair work that dulled the cutting edge of the rongeur, making it necessary to apply greater force during use.The increase in force and the diminished material stability of the cutting edge combined to fracture the tip.Hardness of the returned device was tested, and found to conform to specifications.Review of manufacturing documents showed no nonconformities nor rework.The device conformed to specifications at the time of release.

Event Description

During a laminectomy, a tiny piece of the rongeur tip broke off and fell into the incision area between the lamina and the dura.X-rays were taken.The procedure was completed as planned, and the patient's outcome was fine.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 2MM
• 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: 10832657
• MDR Text Key: 216152426
• Report Number: 8010386-2020-00002
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4258-82T / 2420814ABT
• Device Lot Number: XMEM07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2010
• 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
• Patient Outcome(s): Required Intervention