MAUDE Adverse Event Report: SYNTHES OBERDORF RECIPROCATING SAW ATCH FOR PEN DRIVE; TRAY, SURGICAL INSTRUMENT

Catalog Number 05.001.040

Device Problem Sticking (1597)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the reciprocating saw attachment for pen drive device would not rotate.There were no delays to the planned surgical procedure as spare identical device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown; however, the reporter stated that the event occurred during the month of (b)(6) 2014.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 observed that the ball bearings were damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECIPROCATING SAW ATCH FOR PEN DRIVE
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3827341
• MDR Text Key: 4446538
• Report Number: 8030965-2014-10253
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.040
• Device Lot Number: 1696079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1