MAUDE Adverse Event Report: SYNTHES (USA) 4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM; PLATE,FIXATION, BONE

Catalog Number 226.662

Device Problems Bent (1059); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4) utilized for revision surgery.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.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 the patient experienced left femur pain and x-ray confirmed nonunion, a broken 1.7mm cable with crimp and slightly bent plate.Revision surgery was performed on (b)(6) 2016 during which time all existing hardware was removed (1 plate, cables and an unknown quantity of unknown screws).The patient was revised to a longer plate with additional cables and screws.There was no surgical delay and the procedure was completed successfully.The patient was initially implanted with the complained hardware on (b)(6) 2016 during an open reduction internal fixation (orif) procedure to treat a periprosthetic fracture of the left femur.The fracture was below a previous total hip replacement implant (non synthes).This report is 2 of 2 (b)(4).

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM
• 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: 5801565
• MDR Text Key: 49743494
• Report Number: 2520274-2016-13503
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• 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
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 226.662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• 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: 86 YR