MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS RECIPROCATING SAW ATTACHMENT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 511.902

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: the device does not have power.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Service history review of the device has been performed.The review indicates that the device has not been serviced during the past 6 months.There is no information relevant to the current complaint issue.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: a service and repair evaluation was completed: the device failure reported by the customer could not be confirmed because the defect of the attachment is related to normal wear of a component that has been replaced.The service history review shows no previous service conditions relevant to the current complaint issue.The device has been serviced and functional testing has been performed in accordance with the service manual.During the pre-repair diagnostic assessment the service technician identified the failure code as bearing defect.The service technician identified the probable root cause as normal wear.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: RECIPROCATING SAW ATTACHMENT
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 3814076
• MDR Text Key: 4479137
• Report Number: 3009450871-2014-10143
• Device Sequence Number: 1
• Product Code: GFA
• 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: 04/24/2014

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: 511.902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/23/2014; 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2008
• 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