MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG ULTRA-COAT KERRISON MICRO 40D UP 8 3MM; RONGEURS/KERRISONS/IVDS

Catalog Number RB5863 / 130814BZ

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2013

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.It was not possible to review manufacturing records, since the lot # was unavailable.Since the device was not available for testing and evaluation, the cause of the problem cannot be established.(b)(4).

Event Description

Surgeon was performing a right l5-s1 microdiscectomy.Surgeon took a regular bite of bone from subarticular recess and device broke.Patient was not harmed.X-ray was not taken because broken piece was removed via microscope and matched with other piece to make sure.Customer reports device is "very old", at least 8 years old.

• Brand Name: ULTRA-COAT KERRISON MICRO 40D UP 8 3MM
• Type of Device: RONGEURS/KERRISONS/IVDS
• 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 ; 4619668540
• MDR Report Key: 5472566
• MDR Text Key: 39423694
• Report Number: 8010386-2016-00004
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RB5863 / 130814BZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR