MAUDE Adverse Event Report: AESCULAP AG TUNNELING INSTRUMENT 600MM

Model Number FV004R

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).During surgery and positioning of tunneling instrument, the suture part tear off from plastic tip.The plastic tip detached from tunnel and get stuck in tissue of clavicula area.

• Brand Name: TUNNELING INSTRUMENT 600MM
• Type of Device: TUNNELING INSTRUMENT 600MM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5114962
• MDR Text Key: 27177193
• Report Number: 2916714-2015-00867
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2018
• Device Model Number: FV004R
• Device Catalogue Number: FV004R
• Device Lot Number: 51987195
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other