MAUDE Adverse Event Report: SYNTHES MONUMENT 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.252S

Device Problems Break (1069); Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2011

Event Type  malfunction  

Event Description

Upon receipt of a package for a reamer head, it was noted that one of the prongs had broken off.No patient involvement.

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.Additional investigation showed that there were no issues that would contribute to this complaint condition.This complaint is indeterminate from a manufacturing standpoint because the missing portion of the product makes physical dimensional verification impossible.Placeholder.

• Brand Name: 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER/IRRIGATOR/ASPIRATOR
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: anand agarwal ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4347845
• MDR Text Key: 5173603
• Report Number: 1719045-2014-00182
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: K01352
• 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
• Report Date: 11/29/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 352.252S
• Device Lot Number: 6408212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2011
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2011
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2010
• Patient Sequence Number: 1
• Treatment: 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASP
• Patient Outcome(s): Required Intervention