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

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.

• Brand Name: VM RHOTON SELLA PUNCH 1 MM WIDE UPCUT 45 DEG
• Type of Device: MANUAL RONGEUR
• Manufacturer (Section D): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• MDR Report Key: 7619531
• MDR Text Key: 112439546
• Report Number: 8010386-2018-00005
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL3785-164 / 0110814
• Device Lot Number: XMEA 03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 107