MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient was experiencing severe pain so a revision procedure was performed.After removing a plate, it was discovered that it had rusted on the cortical screw section of the combi-holes; the locking holes seemed un-affected.The device had been in the patient since (b)(6) 2014.This report is for an unknown screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4) low patient ph balance that occurred as a result of the rusted device.Device 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

Update: per the surgeon, the damage/rust on the plate caused a low ph balance in the patient.

Manufacturer Narrative

(b)(4) patient's low ph balance.It is unknown if the rust caused the low ph balance or if the low ph balance caused the rust.Device 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.

• Type of Device: SCREW, FIXATION, BONE
• 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: 4998500
• MDR Text Key: 22808221
• Report Number: 2520274-2015-15203
• Device Sequence Number: 1
• Product Code: HWC
• 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,foreig
• Reporter Occupation: Other
• Report Date: 07/17/2015

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: Not provided
• Initial Date FDA Received: 08/12/2015
• 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