MAUDE Adverse Event Report: SYNTHES MONUMENT SLAP HAMMER WITH QUICK RELEASE; SCREW DRIVER

Catalog Number 03.809.690

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2012

Event Type  malfunction  

Event Description

The consultant reports regarding a lateral interbody fusion, l3-4.During the procedure, the end of the hammer broke off.There were no pieces to retrieve.The surgeon completed the surgery without further incident and no adverse effect to the patient was noted.This complaint is 1 of 1 for complaint number (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.A device history record (dhr) review was performed and the mrb engineer determined that the correct material was used and the ncr was dispositioned ¿use as is¿.Placeholder.

• Brand Name: SLAP HAMMER WITH QUICK RELEASE
• Type of Device: SCREW DRIVER
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4346744
• MDR Text Key: 5177952
• Report Number: 1719045-2014-00166
• Device Sequence Number: 1
• Product Code: FZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.809.690
• Device Lot Number: 6723847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1