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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG MANUAL RONGEUR

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S.U.A. MARTIN GMBH &CO.KG VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG MANUAL RONGEUR Back to Search Results
Catalog Number NL3785-164 / 0110814
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
The device was manufactured in 1998 and the photographs provided by the distributor show signs of considerable wear. The manufacturer is awaiting return of the device to perform a complete evaluation.
 
Event Description
Medwatch report states: #1 kerrison instrument used during posterior cervical instrumentation. Tip of kerrison noted to have broken off during procedure. Radiographic confirmation obtained that tip of instrument was not retained in patient. Suction filter was radiographed and tip found to be seated in filter of the suction machine. Cpd (central processing department) manager notified. Broken instrument isolated w/ suction filter and given to central processing department who dismantled suction filter and sifted piece out. What was the original intended procedure?: decompression and fusion posterior cervical spine one lever- c2-c7 fusion posterior cervical spine three or more levels- laminectomy cervical spine with decompression and instrumentation two levels patient was not harmed in this incident. On 11may2018 additional information: 1. Is it normal procedure to take an x-ray of the patient or was this only done to verify the location of the broken tip of the instrument? it is standard procedure to have c-arm (x-ray) in the room during this procedure. X-ray is used to confirm placement of instrumentation during and immediately prior to patient leaving the operating room (or).
 
Manufacturer Narrative
The cutting edge of the jaw was very dull due to wear and lack of maintenance. Great force would have been required to use the device, causing the tip to break. Hardness testing results conformed to specifications. No material defect was found. Product lifetime has been exceeded by 17 years. The customer was reminded to inspect instrument's condition prior to each use.
 
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Brand NameVM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
MDR Report Key7619531
MDR Text Key112439546
Report Number8010386-2018-00005
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL3785-164 / 0110814
Device Lot NumberXMEA 03
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

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