MAUDE Adverse Event Report: SYNTHES USA SMALL BATTERY DRIVE 14.4V BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 532.033

Device Problem Low Battery (2584)

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

Event Type  malfunction  

Event Description

Veterinary event: facility contact reported the small battery drive 14.4v battery is not working.Fully charged battery was removed from the charger and inserted into the drill.After the drill was used for 1 or 2 screws, battery no longer had enough charge to finish drilling holes for the implant.Another drill was used to complete the procedure.A surgical delay was reported, was greater than 14 minutes but less than 30 minutes.There was no human involvement.Being returned to be tested because the battery is less than a year old.(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4): subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Device is an instrument and is not implanted/explanted.Unknown date in (b)(6) 2014.(b)(4).No patient information will be reported.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Service history of the past six months from the awareness date was reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is unknown if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.An investigation was completed: the customer's complaint that the ((b)(4)) small battery drive 14.4v does not hold charge could not be confirmed.The device was tested and passed all operational specifications.The device has been returned to the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMALL BATTERY DRIVE 14.4V BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3679524
• MDR Text Key: 4242449
• Report Number: 2520274-2014-10260
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.033
• Device Lot Number: D130411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1