MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT

Catalog Number 05.001.202

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

This is report 5 of 5 for the same event.It was reported from (b)(6) that during pre-operative testing, it was observed that the handpiece device, power module device and the lid for the handpiece device did not work ¿suddenly¿.It was stated that there was ¿no problem at clinical use¿.According to the report, there were two handpiece devices and two power module devices involved in this event.The reporter stated that the ¿operation was not confirmed in condition of being inserted of the power module at first, but was confirmed a second time¿.It was further clarified that a self-check function of the power module was performed and no abnormality was found.This event was not related to surgery.There were no delays to a scheduled surgical procedure.The report indicated that there was patient involvement.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.

Event Description

Device report from synthes (b)(4) is reporting an event in (b)(6).This is report 3 of 5 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.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.A product development evaluation was completed: the described failure of the trauma recon system could not be replicated.Both modules as well as the hand piece are working accurate.Not waiting 1-2 seconds after switching from lock to one of the other positions was the possible cause of the issue.The service history noted: 05.001.201; 4493 batt-handpiece mod f/trs: no service since (b)(4) 2011; 05.001.227; 3894 lid f/batt-handpiece no.05.001.201 f/tr: no service since december 2010; 05.001.227; 4066 lid f/batt-handpiece no.05.001.201 f/tr: no service since (b)(4) 2011.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: POWER MODULE FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT
• 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: 3725289
• MDR Text Key: 4278021
• Report Number: 3009450871-2014-10072
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDPIECE DEVICE; LID DEVICE