MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4C SET SCREW NEW VERSION; CERVICAL STABILISATION

Model Number SW003T

Device Problems Difficult To Position (1467); Device Damaged Prior to Use (2284)

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

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that due to the thread of sw151t being damaged and it did not connect to sw011t.Tape was used to connect to another c4 device without the screws and the procedure was completed.Components in use listed as concomitant devices are: sw003t / s4c, set screw new version (2).Sw151t / s4c, favoured angle screw 4.0x30mm.Sw011t / s4c, 11mm l-shpd.Lat.Offset connector lt.All med watch submissions related to this related to this report are: 9610612-2017-00011.9610612-2017-00012.3005673311-2016-00210.

Manufacturer Narrative

Investigation: the component has been examined visually and microscopically with a keyence vhx-5000 digital microscope.The hexagon has usage traces and is workable.The contact surface has an imprint, probably of an connection rod.The thread has burrs at the beginning of the thread and abrasion of the thread flanks.Batch history review: the device history file has been checked and found to be according to our specification valid at the time of production.Conclusion and root cause: based on the information available, as well as the result of our investigation, the root cause of the failure is most probably user related.Rational: the screws were, due to their wear traces, several times tightened and loosened which corresponds to our information from the surgery with different problems to manage the situation.There are no hints for the material or design failures.No capa is necessary.

• Brand Name: S4C SET SCREW NEW VERSION
• Type of Device: CERVICAL STABILISATION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 6243334
• MDR Text Key: 64589386
• Report Number: 9610612-2017-00011
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• 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: 52209978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/05/2016
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SW003T / S4C SET SCREW NEW VERSION; SW011T / S4C 11MM L-SHPD.LAT.OFFSET CONNECTOR LT; SW151T / SC4 FAVOURED ANGLE SCREW 4.0X30MM
• Patient Outcome(s): Other