MAUDE Adverse Event Report: SYNTHES MONUMENT HAND PIECE FOR BATTERY POWERED DRIVER; SCREWDRIVERS

Catalog Number 05.000.008

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

It was reported that, battery powered device, and the handpiece worked for one procedure.During a second procedure, sterile battery was placed attached and the device would not power.It was reported that subject device was cleaned and sterilized per facility procedure, but was not submerged in water.This is report 1 of 1 for complaint (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.Device was used for treatment, not diagnosis.Additional product code, gxl.Returned to manufacturer.A review of the device history shows revealed the hand piece for battery powered driver was processed per all specification requirements.The product conformed to the synthes incoming final inspection sheet.There were no complaint-related anomalies, mrrs, or ncrs associated with this part.Certificate of compliance indicates the correct material was used and met the required specifications and functions.The unit was received.After being inspected, it was determined that unit's motor had failed.The motor was replaced along with applicable components.The unit now meets and passes all minimal acceptance criteria, and was returned to the customer.Item was received intact.Item was sent to repair and the repair techs coded this as mfr (motor failure).It was repaired and sent back to the customer.Deemed indeterminate.Placeholder.

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Type of Device: SCREWDRIVERS
• 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: 4346510
• MDR Text Key: 20126510
• Report Number: 1719045-2014-00188
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/12/2011

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: Other Health Care Professional
• Device Catalogue Number: 05.000.008
• Device Lot Number: 004060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2011
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1