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 Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the device did not hold a saw blade device.During service/repair, it was observed that the damaged set screw threads came off.The assignable root cause was determined to be due to normal wear out from use.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during pre-surgery, before the patient was in the room, it was discovered that the recon sagittal saw device was not holding the saw blade device while being used with two other recon sagittal saw devices.During in-house engineering evaluation, it was observed that the damaged set screw threads came off.There were no delays to the surgical procedure as spare devices were available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was noted that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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: 7390379
• MDR Text Key: 104212905
• Report Number: 8030965-2018-52525
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819462588
• UDI-Public: (01)7611819462588(11)130610
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Date Manufacturer Received: 03/08/2018
• Date Device Manufactured: 06/10/2013
• 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