MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY OSCILLATOR II; MOTOR,SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710

Device Problems Loss of Power (1475); Device Stops Intermittently (1599)

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

Event Date 08/13/2013

Event Type  malfunction  

Event Description

This is report 1 of 3 for the same event.It was reported that during a bilateral total knee arthroplasty, it was observed that the battery oscillator device did not have enough power.It was further reported that there was an insufficient ease of inserting and removing pins on the pin driver device.Additionally, it was reported that the pin driver device had insufficient lever function.The reporter stated the there was also an insufficient ease of inserting and removing wires on the wire driver device.Additionally, it was reported that the wire driver device had insufficient lever function.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.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

Additional narrative: please note the initial medwatch represents the battery oscillator ll that was used in the procedure.Please note that two additional devices (quick coupling devices) were also used in the procedure.Therefore, two additional medwatch reports, representing these devices, will be created to capture the events.

Event Description

This complaint was part of a market preference evaluation which records the complaint aspects of mpe results.The drive units were used in a bilateral total knee arthroplasty (2-tka's) on (b)(6) 2013.It was reported to be heavy, do not have enough power, the controls for forward / reverse, insufficient ease of drilling, insufficient ease of reaming, insufficient ease of oscillating sawing, insufficient design and handling of sagittal saw head, insufficient weight to power ratio.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product code: moq.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.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: BATTERY OSCILLATOR II
• Type of Device: MOTOR,SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• 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: 4128684
• MDR Text Key: 5095877
• Report Number: 3009450871-2014-10434
• Device Sequence Number: 1
• Product Code: GEY
• 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
• Report Date: 09/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• 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: Unknown
• Patient Sequence Number: 1