MAUDE Adverse Event Report: AESCULAP AG S4C SET SCREW NEW VERSION; BONE SCREW

Model Number SW003T

Device Problem Defective Device (2588)

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

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint: screw damaged during insertion.Operation was delayed over 15 minutes.Unable to complete final fixation of sw003t.Review indicated screw was damaged.The damaged screw was replaced with another sw003t and operation was completed without further incident.No patient hazard was reported.Device scrapped at facility, not available for eval.

Manufacturer Narrative

U.S.Reporting agent notified on: (b)(4) 2015.Manufacturing sire eval: eval on-going.

Manufacturer Narrative

The evaluation was done on the basis of the currently available information.As no sample was received, no investigation could be conducted.The device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.One more complaint has been filed with products from this batch.There is no indication of a material or product failure.

• Brand Name: S4C SET SCREW NEW VERSION
• Type of Device: BONE SCREW
• Manufacturer (Section D): AESCULAP AG; tuttlingen 78532 ; GM 78532
• 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: 4960933
• MDR Text Key: 6037958
• Report Number: 3005673311-2015-00090
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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
• Device Lot Number: 51968443
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other