MAUDE Adverse Event Report: SYNTHES GMBH SMALL BATTERY DRIVE 14.4V BATTERY; BATTERY, REPALCEMENT, RECHARGEABLE

Catalog Number 532.033

Device Problems Failure to Charge (1085); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Material Separation (1562); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the surgeon was using the small battery drive and it was working intermittently.It was thought that the battery and they replaced the battery two times.The scrub nurse asked for another drill and while the drill was on the back table they noticed a burning smell.The drill was hot to the touch, the casing was separated and they removed the battery which had started to melt.No injury to any hospital staff or the patient.The two batteries that were swapped out in the small battery drive will no longer hold a charge.They removed the drill, casings and the batteries.There was no report of time delay.Update: additional information was provided on (b)(4) 2013 per telephone call.The hospital central sterile representative reported: all this occurred at set up, before the patient was in the room.Hospital is not returning any device related/patient related information to the complaint handling unit; the hospital declined completion of the synthes questionnaire.This is report 3 of 3 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.Event date unknown.The device is an instrument, not implanted/explanted.Subject device will not be returned for an evaluation.The manufacturing documents were reviewed and no complaint related issues were found.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.

• Brand Name: SMALL BATTERY DRIVE 14.4V BATTERY
• Type of Device: BATTERY, REPALCEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4347576
• MDR Text Key: 16453930
• Report Number: 8030965-2014-01644
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2011

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: Health Professional
• Device Catalogue Number: 532.033
• Device Lot Number: MD090410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1