MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM; MANUAL RONGEUR

Catalog Number 2130814BT / NL 4252-83T

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Correction of event description: examination of the returned device and the broken-off footplate showed that the footplate broke off in a single piece, not several pieces as implied by the initially reported description of the event.The device was subject to microscopic examination by the manufacturer.Visible grinding marks on the slider, handle and tip indicate that it had been repaired and modified by an unauthorized and unknowledgeable third party.The foot plate had been ground by the repair site, reducing material stability and increasing the risk of breakage.This effect was augmented by modification of the limit stop of the handle, permitting greater pressure to be applied to the foot plate during use than intended by the device manufacturer.Manufacturing records were reviewed and no anomalies found.Hardness testing showed that the returned device conformed to specifications.

Event Description

Per hospital report, dr.(b)(6) was using a 3mm kerrison on a lumbar fusion and the foot plate broke.All the pieces were removed from the patient.No further information available.

• Brand Name: VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM
• Type of Device: MANUAL 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: 9210020
• MDR Text Key: 214346506
• Report Number: 8010386-2019-00003
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2130814BT / NL 4252-83T
• Device Lot Number: XMEI05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2008
• 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