MAUDE Adverse Event Report: SYNTHES USA 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a valid 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.Dhr review - part/lot combination unknown at synthes (b)(4), therefore no dhr review possible.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 an intramedullary nail of a tibia surgery on (b)(6) 2016.During the procedure, a blocking screw was set in place prior to the reaming process.While the surgeon was trying to navigate past the block, the reamer head hit the screw block and the head and shaft broke.The fragments landed in the patient's bone and were not able to be retrieved.No surgical delay was reported.The procedure was completed by completing the reaming process with the next size up reamer.This is report 2 of 2 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• 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: 5377719
• MDR Text Key: 36338714
• Report Number: 2520274-2016-10327
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 645625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention