MAUDE Adverse Event Report: AESCULAP AG AND CO. KG S4 SET SCREW NEW VERSION

Model Number SW90T

Device Problems Break (1069); Disconnection (1171); Material Separation (1562); Improper Chemical Reaction (2952); Naturally Worn (2988)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 10/31/2013

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Pt complaint of pain some time post operative.During revision operation, it was discovered that the s construct was disconnected.One inlay was totally separated from the screw and on the opposite side, another inlay was halfway out of the screw.The rod on the side where the inlay was out was quite damaged, due to wear from the screw rubbing against it.There is evidence of metallosis in the area.Components of inlay (out): sw790t lot 51630902, sw794t lot 51668472, sw661t lot 51584574.Components of inlay (loose): swt90t lot 51670631, sw786t lot 51612922.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: during visual inspection (microscopic) an irregular imprint on the bottom of the set screw from the disconnected side was noted.These markings are not typical for a correctly tightened set screw.The second set screw exhibited a light "figure eight" pattern.The device history record of the two main components was checked and there were no indications fro a material or manufacturing error found.Complaint history shows no further complaints for products of these batches.Failure hypothesis: referring to slight and irregular print on the set screw, it is probable that the screws were not tightened properly.Results of investigation: all indications point to an application error.There are no hints for material or manufacturing error.

• Brand Name: S4 SET SCREW NEW VERSION
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG AND CO. KG; p.o. box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3908051
• MDR Text Key: 4665395
• Report Number: 3005673311-2014-00013
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K032219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SW90T
• Device Catalogue Number: SW90T
• Device Lot Number: 51630902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other