MAUDE Adverse Event Report: SYNTHES MONUMENT HAND PIECE FOR BATTERY POWERED DRIVER; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 05.000.008

Device Problem Device Stops Intermittently (1599)

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

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part number: 05.000.008, synthes lot number: 006123: release to warehouse date: april 14, 2015.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported the patient underwent a cranial plating and during the procedure the driver stopped working when pressure was applied to the bone.The surgeon was attempting to implant screws when the driver stopped working pressed up against bone.The staff quickly replaced the driver.No surgical delay was reported.No harm was reported to the patient and the procedure was completed successfully with another driver.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned device was examined and no discernible defect or deficiency was identified on the device casing.The complaint condition was unable to be replicated as a mating battery was not returned.A visual inspection, service evaluation, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.It was reported the patient underwent a cranial plating and during the procedure the driver stopped working when pressure was applied to the bone.The surgeon was attempting to implant screws when the driver stopped working pressed up against bone.The staff quickly replaced the driver.No surgical delay was reported.No harm was reported to the patient and the procedure was completed successfully with another driver.In addition, review of the attached complaint histories does not show any similar events.Complaint was determined to not be a part of recall z-1456-2014.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.It was reported the patient underwent a cranial plating and during the procedure the driver stopped working when pressure was applied to the bone.The surgeon was attempting to implant screws when the driver stopped working pressed up against bone.The staff quickly replaced the driver.No surgical delay was reported.No harm was reported to the patient and the procedure was completed successfully with another driver.In addition, review of the attached complaint histories does not show any similar events.

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5660970
• MDR Text Key: 45366547
• Report Number: 1719045-2016-10409
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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: 05.000.008
• Device Lot Number: 006123
• Other Device ID Number: (01)10887587024585(10)006123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1456-2014
• Patient Sequence Number: 1