MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device evaluated by mfg.Patient information not available for reporting.Additional product code: hrs, hwc.(b)(4).Not implanted, retained fragment.The proximal portion of the screw was explanted.Initial reporting facility unknown.(b)(4): this event resulted in a retained fragment.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Device is not expected to be returned for manufacturer review/investigation.Device not available for evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Customer quality unit received a maude report forwarded from (b)(6); this maude report against user facility report # 5177064.Only additional and/or corrected information will be contained in this report.It was reported that during a surgical procedure on (b)(6) 2015, a screw fractured when placed in left femur.The proximal portion of the screw was removed, the distal portion was left in the bone.There is no additional information available regarding patient outcome, procedure or delay.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 5746793
• MDR Text Key: 48101476
• Report Number: 2520274-2016-13269
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• 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
• Date Manufacturer Received: 06/27/2016
• 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