MAUDE Adverse Event Report: SYNTHES USA 3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/6H/RIGHT/135MM; PLATE, FIXATION, BONE

Catalog Number 02.112.514

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2015 a patient underwent an open reduction internal fixation pilon surgical procedure for treatment of a distal tibia fracture.During the attachment of the insertion handle to the plate, the insertion handle connection screw locked in the plate.The screw would not advance and properly seat into the plate, leaving the aiming arm unable to be used.When an attempt was made to back the screw out of the plate, the head snapped, leaving a portion of the connection screw locked into the plate.A larger plate was selected.There was a fifteen minute delay.The procedure was successfully completed with no apparent consequences to the patient.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown lot number.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This device was used for treatment not diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/6H/RIGHT/135MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrighgts lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4442286
• MDR Text Key: 5316343
• Report Number: 2520274-2015-10529
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK013248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.112.514
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• 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