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

Catalog Number CSR60

Device Problems Bent (1059); Scratched Material (3020); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

Device returned for repair.During service, the technician found that the drive shaft was bent, the reduction gear had strongly scratched and the attachment got hot.The attachment had remainders of cleaning agent and could not be disassembled.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: synthes is submitting this report as a result of remediation activities related to synthes 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.Manufacturing date for this device is unavailable.During pre-repair assessment performed by a technician, functional testing was performed and revealed the component was damaged.This was contributed to improper handling of the device.Various parts were replaced.Device was repaired and returned to the customer.

• 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: 4183205
• MDR Text Key: 5088531
• Report Number: 1045834-2014-14375
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/13/2013

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 Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2013
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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