MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.416

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient dob, gender and weight not provided by reporter.Additional product code ¿ hrs, hwc.(b)(4).Device was reportedly kept in patient as it was stabilizing; not explanted (b)(6).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.Mfr date: unknown.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: patient needed a revision open reduction internal fixation (orif) surgery on the right distal femur after falling and breaking the variable angle (va) condylar plate broke at the proximal third of shaft.During surgery, four (4) proximal screws and two (2) cables were removed along with the portion of the plate proximally to where the plate broke.The breakage was through a screw hole.Patient was revised to have an antegrade nail to stabilize proximal shaft fracture line while a vaco plate was left in place as it was still stabilizing a distal shaft fracture (original fracture was segmental).Surgeon was happy with fixation achieved.He felt the plate breakage was due to a long term atrophic non-union with poor bony biological healing properties combined with the insult of the fall all contributed to the plate breakage.This is report 1 of 2 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 5225608
• MDR Text Key: 31315193
• Report Number: 2520274-2015-17265
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• 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