MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG TA KERRISON RONGEUR 8IN 1MM BITE 40 UP

Catalog Number NL4291-81T / V0110814ZBAT

Device Problems Fracture (1260); Inadequate Service (1564); Dent in Material (2526)

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Hardness of all rongeur components was tested and found conforming to specifications. Manufacturing records were reviewed and found to be conforming. The instrument and broken-off tip were subject to microscopic examination. Several deep indentations in the material indicate that it was used to cut and/or manipulate thin, hard objects such as metallic wire. This does not correspond to its intended use (cutting of tissue and bone) and led to a reduction in material stability. Evidence of unauthorized third-party repairs was also observed, e. G. Grinding of tip and cutting edges as well as of the shaft guide, which was shortened at the distal end, thus also reducing material stability and increasing the risk of fracture.

Event Description

During a procedure it was noticed that the footplate of the kerrison had broken off. The patient was x-rayed to ensure the broken piece had not fallen inside the patient's body. The piece was found on the patient's top drape. No harm was reported.

• Brand Name: TA KERRISON RONGEUR 8IN 1MM BITE 40 UP
• 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 ; 4619668540
• MDR Report Key: 6442309
• MDR Text Key: 71221773
• Report Number: 8010386-2017-00001
• 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

• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: NL4291-81T / V0110814ZBAT
• Device Lot Number: XMEV05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse