MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.240

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Reporter's phone number was not provided.The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the trigger of the sagittal saw device was blocked, jammed, and moving heavily.It was noted that the magnetic support coupling was broken.It was further determined that the device failed pretest for check proper function of the trigger.It was noted in the service order that the device was faulty and not working properly.This event did not occur during surgery.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 will be submitted accordingly.

• Brand Name: RECON SAGITTAL SAW WITH KEY FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7148389
• MDR Text Key: 95848042
• Report Number: 8030965-2017-50978
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819462588
• UDI-Public: (01)7611819462588(11)120703
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Date Manufacturer Received: 12/06/2017
• Date Device Manufactured: 07/03/2012
• 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