MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY-CAS F/NOS. 532.101+532.110 W/LOC; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.132

Device Problems Melted (1385); Overheating of Device (1437); Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 7 of 7 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the small battery drive device had no power.According to the report, the event was discovered twenty minutes after putting a new and fully charged battery device in place and when the surgeon was about to use the small battery drive device.It was further reported that when the scrub staff went to change the battery device for another, the battery inside the battery casing device was observed to be extremely hot and had melted in parts.During subsequent follow-up, the reporter stated that there were two additional small battery drive devices that would not run and two additional battery casing devices with unknown failures associated with this event.There was a five minute delay to the surgical procedure.A spare drill device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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 observed that the battery casing did not pass the leak test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATTERY-CAS F/NOS. 532.101+532.110 W/LOC
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5384974
• MDR Text Key: 36640703
• Report Number: 8030965-2016-10430
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: 532.132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2013
• 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