MAUDE Adverse Event Report: SYNTHES USA; EXTRACTOR

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for two (2) 3.5 talonavicular screw /unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 patient experienced a right foot deformity and underwent a right ankle pantalar arthrodesis using a proximal humerus internal locking system (philos).Upon radiologic follow-up post-operatively, it was found that the ankle did not fuse and formed a non-union, with hardware failure.Of the eighteen (18) pieces of the hardware implanted, only four (4) pieces were intact.On the sixth year post-operative, the patient complained of a new onset pain in her operative ankle.A removal of the hardware and revision of the ankle was planned.The revision surgery implemented a pediatric distal femoral osteotomy plate.There is no follow-up data on the revision.Concomitant medical products: four (4) unknown screws (part # unknown, lot # unknown), one (1) 6.5mm cannulated screw (zimmer) (part # unknown, lot # unknown).This report is for two (2) 3.5 talonavicular screw.This is report 1 of 4 for (b)(4).

• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6498783
• MDR Text Key: 72984362
• Report Number: 2520274-2017-11343
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/17/2017
• 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: FOUR (4) UNKNOWN SCREWS; ONE (1) 6.5MM CANNULATED SCREW (ZIMMER)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR