MAUDE Adverse Event Report: AESCULAP AG & CO. KG TUNNELING INSTRUMENT 450MM

Model Number FV003R

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: there was no product available for investigation.Batch history review: we have checked the manufacturing file of batch 51893721, which complies with our specifications and does not present any discrepancy.No other similar incident was declared to us concerning this batch.This was the first complaint with this damage symptoms.

Event Description

Country of complaint: (b)(6).The bullet tip is coming off into the wound, this has happened on two occasions and was retrieved in one incident, the other patient still has the tip in situ as it could not be found.

• Brand Name: TUNNELING INSTRUMENT 450MM
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG & CO KG; p.o. box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3883089
• MDR Text Key: 21170311
• Report Number: 2916714-2014-00099
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: FV003R
• Device Catalogue Number: FV003R
• Device Lot Number: 51893721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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): Other