MAUDE Adverse Event Report: SYNTHES GMBH TI DHS/DCS COMPRESSION SCREW 36MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.990S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 revision for the open reduction internal fixation surgery for trochanteric femur fracture with the implants in question.It is unknown if the patient has fallen and the patient is unable to walk.After the surgery patient happened to have the cut-out.The patient will undergo revision surgery for replacement, with total hip arthroplasty (tha) on (b)(6) 2021 at a different hospital than the first one was operated.Surgeon commented that this cut-out did not seem to be product related and implants were placed appropriately.Surgery was completed successfully with no surgical delay.This report is for (1) ti dhs®/dcs® compression screw 36mm.This is report 5 of 8 for complaint (b)(4).

• Brand Name: TI DHS/DCS COMPRESSION SCREW 36MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11821580
• MDR Text Key: 263631256
• Report Number: 8030965-2021-03917
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819275300
• UDI-Public: (01)07611819275300
• 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: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 480.990S
• Device Lot Number: 21P8013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50