MAUDE Adverse Event Report: AESCULAP AG & CO. KG S4C SET SCREW NEW VERSION

Model Number SW003T

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Short thread on s4c set screw.

• Brand Name: S4C SET SCREW NEW VERSION
• Type of Device: SCREW
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5021300
• MDR Text Key: 24152907
• Report Number: 3005673311-2015-00100
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K050979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW003T
• Device Catalogue Number: SW003T
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other