MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS RECIPROC-SAW-ATTACHM F/COMPACT AIR DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.902

Device Problems Device Slipped (1584); Vibration (1674); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

This is complaint 1 of 4 of the same event.It was reported by (b)(6) that during an unspecified surgical procedure, it was observed the attachment device scratched two saw blade devices when in use with a top sternum device.According to the report, the top sternum device was moving due to vibration, which changed the position.It was further reported that this led to power loss of the device.There were no delays to the surgical procedure.It was not reported if a spare device was available.It was reported that there was no 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.

Manufacturer Narrative

(b)(6).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

The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECIPROC-SAW-ATTACHM F/COMPACT AIR DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: 4654682
• MDR Text Key: 5682297
• Report Number: 3009450871-2015-10952
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• 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: 04/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SAW BLADE DEVICE; TOP STERNUM DEVICE