MAUDE Adverse Event Report: SYNTHES USA; INSTRUMENT, SURGICAL, ORTHOPEDIC PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510(k): report is for an unknown quantity of unknown clamps.(b)(4).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

It was reported that a patient underwent application of an elbow hinge fixator on (b)(6) 2015.On an unknown date, the set screw fell out and the elbow hinge fixator came apart.The patient applied electrical tape to hold the elbow hinge fixator together.On (b)(6) 2015 the patient returned to the operating room and had the elbow hinge fixator and other unknown external fixation rods and clamps removed.There was no surgical delay.Procedure was successful.This report is for an unknown quantity of unknown clamps.This is report 4 of 4 for com-(b)(4).

• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• 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: 5144084
• MDR Text Key: 28026758
• Report Number: 2520274-2015-16605
• Device Sequence Number: 1
• Product Code: HSZ
• 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
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• 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