MAUDE Adverse Event Report: SYNTHES OBERDORF RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.240

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).(b)(6).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.

Event Description

This is report 2 of 2 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that it was not possible to close the lid of the sagittal saw handpiece device because either the lid of the sagittal saw handpiece device was deformed, or the sagittal saw device was deformed.It was reported that there was a ten minute delay in the procedure and an unspecified spare device was available to complete the procedure successfully.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.It was reported that the patient is in good condition.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 was returned for evaluation.Reliability engineering evaluated the device and observed that it was not possible to lock the lid on the handpiece, the protection ring was not properly adjusted and the housing was deformed.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to the design being faulty.A capa has been initiated to address this issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5978108
• MDR Text Key: 55989265
• Report Number: 8030965-2016-14993
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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
• Treatment: LID DEVICE