MAUDE Adverse Event Report: SYNTHES OBERDORF RECIPROCATING SAW ATCH FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.040

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that the reciprocating saw attachment device was frozen and not functioning.During an in-house engineering evaluation, it was observed that the device was found to run but heated up.It was also noted that the device had damaged bearings and worn and damaged drive shaft and eccentric coupling.It was also noted that the device had a damaged needle bearing (one needle came out) and worn cone sleeve.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: RECIPROCATING SAW ATCH FOR PEN DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: 5582723
• MDR Text Key: 43633042
• Report Number: 8030965-2016-13036
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• 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: 1384121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1