MAUDE Adverse Event Report: SYNTHES USA; REAMER

Device Problems Fitting Problem (2183); Mechanical Jam (2983)

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

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.This report is for one (1) unknown reamer tube assembly.(other): without a valid part and lot number, the udi is not available.Device is an instrument and is not implanted or explanted.Per facility, the complainant parts were discarded and are no longer available for evaluation.As specific part and lot numbers for the complainant reamer tube assembly were not provided.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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

It was reported that a reaming head and reaming tube assembly could not be disconnected from a reamer/irrigation/aspirator (ria) shaft following the completion of an unknown surgical procedure on (b)(6) 2016.The issue was discovered post-operatively.The procedure itself was completed successfully without any delay or patient harm.This report is for one (1) unknown reamer tube assembly.This report is 3 of 3 for (b)(4).

• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5684991
• MDR Text Key: 46087114
• Report Number: 2520274-2016-12904
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• 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