MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS UNKNOWN BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number UNKNOWN

Device Problems Mechanical Problem (1384); Device Inoperable (1663)

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

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

The part number as unknown.All attempts to obtain product information were unsuccessful.Therefore, udi is unavailable.The brand name is unknown the manufacturing location is unknown.The catalog number, lot/serial number is unknown.Pma/510(k) number is unknown device manufacture date: the device manufacture date is unavailable.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 2 for the same event.It was reported that during an unspecified veterinary surgical procedure, it was observed that the small battery drive handpiece device was working normal initially but would cut out gradually and intermittently while in use with the battery device.The reporter stated that the event was either handpiece or (less likely) battery related.It was reported that there was a delay in the procedure; however, the length of delay was not provided.It was not reported if a spare device was available for use.There was no human patient involvement as this was a veterinary procedure.There were no patient or user injuries reported.It was reported there was no 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.

• Brand Name: UNKNOWN BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6476672
• MDR Text Key: 72559806
• Report Number: 8030965-2017-11726
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2017

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: UNKNOWN
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SMALL BATTERY DRIVE DEVICE