MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP DHHS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 282.671S

Device Problems Premature Activation (1484); Sticking (1597)

Patient Problem No Information (3190)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

It was reported that when the surgeon attempted to implant the helical blade implant into the patient's left femur, the implant did not detach from the insertion tool as it should.A second helical blade implant was attempted successfully.The sideplate component was attempted, but the flanges of the barrel expanded prematurely.This implant system was abandoned and replaced with a synthes dhs implant system.

• Brand Name: DHHS
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1303 goshen pkwy; west chester PA 19380
• MDR Report Key: 6940122
• MDR Text Key: 88972537
• Report Number: 6940122
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 09/01/2023
• Device Model Number: 282.671S
• Device Catalogue Number: 282671S
• Device Lot Number: 7793885
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE INCIDENT INVOLVED MULTI-PART INSTRUMENTATION T
• Patient Age: 30 YR