MAUDE Adverse Event Report: AESCULAP AG AND CO. KG S4 MONOAXIAL SCREW 6.0X45MM; BONE SCREW

Model Number SW726T

Device Problem Material Distortion (2977)

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

Event Date 06/16/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The thread of the screw head broke during insertion, another screw was used.Surgery delay more than 15 minutes.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: microscopic analysis indicated that the threads of both monoaxial screws show visible damage.Most likely cause for this type of damage is that the screw was crossthreaded.The shearing off of the thread indicates high forces were exerted.This failure is likely user related.The manufacturing records were reviewed and found to be according to specification valid at the time of production.There are no indications for a material or manufacturing defect of either screw.

• Brand Name: S4 MONOAXIAL SCREW 6.0X45MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen ; GM
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4359486
• MDR Text Key: 5232722
• Report Number: 3005673311-2014-00090
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K032219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW726T
• Device Catalogue Number: SW726T
• Device Lot Number: 514948201/51950233
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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