MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG TA KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP

Catalog Number NL4291-84T / 1640814ZBAT

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Type  malfunction  

Manufacturer Narrative

The returned device was inspected.Hardness of device was tested and found to be conforming to specifications.Original manufacturing and quality control records were reviewed and found to be conforming.The returned device was incomplete, i.E., the screw was missing.Evidence of third-party rework and repair was observed.Apparently the screw had been removed and was not correctly fixated again after unauthorized repair and rework activities.

Event Description

During a procedure, the screw fell out of the rongeur.No harm to patient was reported.

• Brand Name: TA KERRISON RONGEUR 8IN 4MM BITE 40 DEG. 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
• MDR Report Key: 6865305
• MDR Text Key: 86150956
• Report Number: 8010386-2017-00006
• 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: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4291-84T / 1640814ZBAT
• Device Lot Number: XMEV02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2013
• 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