MAUDE Adverse Event Report: SYNTHES USA 3.5MM CORTEX SCREW SELF-TAPPING 55MM; PLATE,FIXATION,BONE

Catalog Number 204.855

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Not explanted; device is not expected to be returned for manufacturer review/investigation.It was reported the screw broke during insertion.A portion of the screw was left in the patient, which resulted in a unintended retained fragment.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an unknown procedure on (b)(6) 2016, two 3.5mm screws broke inside patient's femur as the surgeon was screwing them in.Two-thirds (screws were 5.5mm in length) of the screws were left inside the patient.The surgeon used 2 additional screws to complete the procedure without further issues.There was no harm to patient noted and no surgical time delay reported.The patient status was stable.This complaint involves 2 devices.Concomitant device reported: screwdriver (part # unknown, lot # unknown, quantity 1).This report is 2 of 2 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 55MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrigths lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5876727
• MDR Text Key: 52121561
• Report Number: 2520274-2016-14092
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204.855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR