MAUDE Adverse Event Report: SYNTHES USA QUARTER-TUBULAR PLATE WITH COLLAR 5 HOLES/39MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 242.05

Device Problem Break (1069)

Patient Problems Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that a male patient had a hardware removal with revision of a right second metatarsal on (b)(6) 2016.The original open reduction internal fixation (orif) was performed on (b)(6), 2015.The patient subsequently complained of pain and x-rays revealed a broken plate and fracture nonunion.The broken 2.7mm tubular plate and four (4) fully intact cortical screws were explanted.A new 2.7mm tubular plate and four new cortical screws were implanted.The procedure was completed successfully with no harm to the patient.The plate was discarded.(b)(4).

• Brand Name: QUARTER-TUBULAR PLATE WITH COLLAR 5 HOLES/39MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5381068
• MDR Text Key: 36437728
• Report Number: 2520274-2016-10358
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242.05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/20/2016
• 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
• Treatment: 4 UNKNOWN CORTICAL SCREWS
• Patient Outcome(s): Required Intervention