MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS QUINTEX SEMICONSTRAINED SCREW 4.0X16MM; BONE SCREW

Model Number SC503T

Device Problem Disassembly (1168)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

During surgery, two safety rings disassembled from the quintex screws.The screws were left in the patient; only one safety ring could be found.

Manufacturer Narrative

The ring has been visually analysed.Based on the available information, it is not possible to make an assumption about the cause as to why the rings fell out of the screws.The most likely root cause of the failure is design.The ifu (information for use) does not state that the screws must be removed if the ring falls out.Corrective/preventive actions: is necessary and has been initiated.

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
• Type of Device: BONE SCREW
• 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: 5112493
• MDR Text Key: 27177717
• Report Number: 3005673311-2015-00147
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC503T
• Device Catalogue Number: SC503T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• 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