MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY-CAS F/POWER DRIVE F/530.200; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 530.280

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Reporter number (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 3 of the same event.It was reported from (b)(6) that the power drive device and two battery casing devices became very hot making usage almost impossible.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.It was further determined that the seals were stiff.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

During subsequent follow-up with the customer, additional information was received.The reporter stated that event occurred during an unspecified surgical procedure.There were no delays in the surgical procedure as a spare device as available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY-CAS F/POWER DRIVE F/530.200
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5065288
• MDR Text Key: 25925978
• Report Number: 8030965-2015-11450
• Device Sequence Number: 1
• Product Code: MOQ
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2015

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: 530.280
• Device Lot Number: 9058904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2015
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1