MAUDE Adverse Event Report: SYNTHES USA; REAMER

Device Problems Separation Failure (2547); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Report is for one (1) unknown reamer head.Device is an instrument and is not implanted/explanted.(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 while the surgeon was reaming, the reamer head became stuck in the medullary canal.The physician attempted to reverse the drill and the reamer shaft came apart.A ball tip reaming rod was used to remove the parts without difficulty.There was a surgical delay of five (5) minutes.The surgery was successfully completed without further incident.This report is for one (1) unknown reamer head this is report 1 of 2 for (b)(4).

• 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: 5285921
• MDR Text Key: 33172615
• Report Number: 2520274-2015-17773
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• 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: 11/19/2015
• 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
• Patient Age: 84 YR