MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: tfn /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: this report is being filed after the review of the following journal article: hwang, j.Et al.(2020), varus displacement of intertrochanteric femur fractures on injury radiographs is associated with screw cutout, european journal of orthopedic surgery & traumatology, vol.Xx, pages 1-5 ((b)(6)).The purpose of this study was to determine if varus displacement of intertrochanteric femur fractures on injury radiographs is associated with screw cutout after fixation.A total of 366 patients (252 females and 114 males) with a median (interquartile) age of 75 (63¿83) were treated with a short cephalomedullary nails (cmn) or long sliding hip screws (shs).Implants used were dynamic hip screw (synthes, raynham ma) for 21 patients, trochanteric fixation nail (synthes, raynham ma) for 123 patients and trochanteric fixation nails advanced (synthes, raynham ma) for 6 patients.Other brands used were stryker, zimmer and smith and nephew.The median follow-up was 12 (6¿27) months.The following complications were reported as follows: 142 patients presented with varus displacement.9 patients had screw cutouts.(2 from stryker; 5 from zimmer).Eight of the nine cutouts occurred in patients with varus displacement.Seven had poor/adequate reductions.2 patients who were treated with a synthes trochanteric fixation nail had screw cutouts this report is for an unknown synthes dhs, tfn, and tfna.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - constructs: tfn.This is report 3 of 5 (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 11309111
• MDR Text Key: 233141563
• Report Number: 8030965-2021-00933
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• 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