MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PERFORATOR DRIVER WITH HUDSON END; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number CSR60

Device Problem Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

Customer reported that the reducer became unusually warm.Device was returned for repair.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.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.(b)(6).During pre-repair assessment performed by a technician, functional testing was performed and revealed the gears had severe scratches, the drive shaft end play was veiled, and the device was full of detergent and rust.This was attributed to improper maintenance.The device was repaired and returned to the customer on (b)(4) 2013.

• Brand Name: PERFORATOR DRIVER WITH HUDSON END
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4175046
• MDR Text Key: 5163001
• Report Number: 1045834-2014-13515
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK965080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2009
• 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