MAUDE Adverse Event Report: SYNTHES GMBH TI DHS/DCS LAG SCREW 12.7MM THREAD/95MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.950S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a revision surgery on (b)(6) 2020 because the bone union was not confirmed.During the revision surgery the implants were removed and bha surgery was performed.The primary surgery was performed on (b)(6) 2018.No further information is available.This report is for one (1) ti dhs®/dcs® lag screw 12.7mm thread/95mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TI DHS/DCS LAG SCREW 12.7MM THREAD/95MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11143309
• MDR Text Key: 226558325
• Report Number: 8030965-2021-00207
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 480.950S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention