MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 532.103

Device Problems Failure to Run on Battery (1466); Charging Problem (2892)

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

Event Date 07/20/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a pd evaluation was conducted.The report indicates that the examination of this battery shows that one or more than one battery cells are highly resistive.The battery cells have cid (current interrupt device) protection devices to prevent possible dangerous situations.The investigated cells had opened cids.The cid interrupts the current as soon as the pressure in the battery cells rises.As soon as the current is interrupted the pressure won¿t further rise and therefore the cell is in a safe state.According to the test of synthes and the diagnosis of the battery university this happens when the batteries are repeatedly overcharged.Overcharging can only happen if a not adequate battery charger is used.The only adequate and specific battery charger for the colibri ii batteries is the ubc ii (part # 05.001.204) with firmware v11or higher.The complaint failure code has been identified as, battery cells highly resistive.The root cause of failure code could be due to user error, misuse, abuse.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the batteries ran out of power during the surgery and were not able to be charged after.No surgical delay was reported.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The lot number provided (1210103) could not be verified.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.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 14.4 VOLT LITHIUM ION BATTERY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg PA 19380 CH4; SZ 19380 CH44
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4043777
• MDR Text Key: 12491366
• Report Number: 2520274-2014-13330
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.103
• Device Lot Number: 120103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2012
• 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