MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS CASING FOR 14.4V BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.132VET

Device Problems Corroded (1131); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported that during an unspecified veterinary orthopedic surgery, it was observed that the battery casing device would not turn on the drill device when the battery device was inserted.The reporter stated that the device may not be making a connection with the battery device.It was reported that there was corrosion on the prongs on the inside.There was approximately a ten minute delay to the surgical procedure.A spare device was available for use.There was no human patient involvement as the device was used in a veterinary procedure.There were no reports of 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.The casing device was evaluated and the reported condition that the device will not turn on the drill when the battery is inserted as it may not be making a connection with the battery, and there was corrosion on the prongs on the inside was confirmed.An assessment was performed on the device which found that the unit would not turn on the drill when the battery is inserted (no connection), and the contacts were corroded on the inside and the outside.The assignable root cause of this condition was determined to be due to component wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: CASING FOR 14.4V BATTERY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6761049
• MDR Text Key: 81629861
• Report Number: 8030965-2017-14085
• Device Sequence Number: 1
• Product Code: HWE
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.132VET
• Device Lot Number: 4706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2013
• 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
• Treatment: BATTERY DEVICE.; DRILL DEVICE,