MAUDE Adverse Event Report: SYNTHES (USA) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; PLATE, FIXATION, BONE

Catalog Number 202.880

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Please see user facility medwatch report (b)(6) attached to this report.Previously reported information was not duplicated if not necessary.(b)(4).Implant date: unknown date in (b)(6) 2016.Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

User facility medwatch report #(b)(6) was received by synthes customer quality on (b)(6) 2016.Additional information and clarification received from the user facility reported that the patient underwent revision surgery on an unknown date in (b)(6) 2016 due to continued pain and prominent hardware.During the revision surgery one unknown plate and three broken screws were explanted.The three broken screws were located in the proximal portion of the plate.The patient also had an unknown quantity of unknown screws, two unknown competitor k-wires, and possibly other unknown implants which may not have been explanted during the revision surgery.The patient was initially implanted during an open reduction internal fixation (orif) of left first metatarsal was performed on an unknown date in (b)(6) 2015.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

A product investigation was completed: this compliant is confirmed as the returned screws are all broken.Two are broken mid thread and the other is broken under the screw head.Unable to determine a definitive root cause.It is not likely that the design of the devices contributed to this complaint.A visual inspection under 5x magnification, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The relevant tabulated screw drawings were reviewed during this evaluation.No product design issues or discrepancies were observed.The returned parts were determined to be suitable for the intended use when employed and maintained as recommended.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices reported: plate (part and lot unknown, quantity 1), screws (part and lot unknown, quantity: unknown, k-wires (part and lot unknown, quantity 2), other implants (part and lot unknown, quantity: unknown).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5763515
• MDR Text Key: 48618166
• Report Number: 2520274-2016-13337
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202.880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention