MAUDE Adverse Event Report: SYNTHES OBERDORF BATT F/BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.630

Device Problems Mechanical Problem (1384); No Device Output (1435)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable.(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the battery device ran out of power after it was fully charged.During service and evaluation it was found that the battery device was generally worn out.It was not reported if there were any delays in the procedure due to the event.It was reported that there was an unspecified spare battery available and the handpiece ran correctly.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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

Additional narrative: (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.The previous report stated the date of manufacture (dom) was unknown.The dom (jan 27, 2016) has been updated to reflect the date the device was manufactured.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATT F/BATTERY POWER LINE II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6313973
• MDR Text Key: 67211460
• Report Number: 8030965-2017-10692
• Device Sequence Number: 1
• Product Code: GEY
• 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: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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
• Treatment: HANDPIECE DEVICE