MAUDE Adverse Event Report: WEBA MEDIZINTECHNIK GMBH & CO. DECKER RONGEUR CUP 2 X 6MM 6IN

Model Number NL6250

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There were no failures in the hardening process detected during manufacturing.Therefore failed hardening can be excluded.Device was not used as intended.

Event Description

Customer reported via email, that the tip broke off inside the patient and they had to fish it out.On (b)(6) 2015, additional information was obtained.The tip broke off during a lumber one level procedure.A c-arm x-ray was used to verify.There was no patient impact and the procedure was completed as planned.

• Brand Name: DECKER RONGEUR CUP 2 X 6MM 6IN
• Type of Device: NA
• Manufacturer (Section D): WEBA MEDIZINTECHNIK GMBH & CO.; schlossackerweg 611; balgheim 78582 ; GM 78582
• Manufacturer Contact: schlossackerweg 611; balgheim 78582 ; 9742495826
• MDR Report Key: 5245391
• MDR Text Key: 32103412
• Report Number: 8010282-2015-00004
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NL6250
• Device Catalogue Number: NL6250
• Device Lot Number: XWAV02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2015
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1