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

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

Patient Problem Deformity/ Disfigurement (2360)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: tfna/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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: usami t., et al (2021) banding with lesser trochanter fragment using nonabsorbable tape in trochanteric femoral fractures, sicot-j volume 7, 33 pages 1-7 (japan).This retrospective study aims to investigate the bone union ratio of the lesser trochanter fragment, lesser trochanteric deformity, and postoperative complications after the treatment of trochanteric fracture with the lesser trochanter fragment using a proximal intramedullary nail and nonabsorbable tape.From january 2014 to december 2017, 114 trochanteric fracture patients medical records with lesser trochanter fragments treated using proximal intramedullary nail at a single trauma center (kainan hospital, yatomi, japan) were reviewed.The inclusion criteria included unstable trochanteric fractures with displaced lesser trochanter fragment (ao/ota 31-a2 and 31-a3.3 treated using tfna_ (depuy synthes co., ltd., usa, and other competitors devices.73 patients were included in this study.These patients were divided into the lesser trochanter banding group (group b, n = 26),5 males and 21 females, with an average age were 83.5 (79.385.8) years and the no banding group (group n, n = 47), 14 males and 33 females, with average age 84.0 (81.089.5) years.Regarding the nail length, we found that group n tended to use short nails and group b tended to use long nails.The average follow-up period was 21.5 (13.337.9) months in group b and 18.8 (13.631.4) months in group n (p = 0.950).The following complications were reported: in group b, 11 patients exhibited mild deformity, 9 exhibited moderate deformity, and 4 exhibited severe deformity.In group n, 24 patients exhibited severe deformity, 4 exhibited moderate deformity, and 2 exhibited mild deformity.During the follow-up period, 2 patients in group b and 17 in group n showed nonunion.This report is for an unknown synthes tfna.This report is for (1) unk - constructs: tfna this report is 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFNA
• 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: 12158040
• MDR Text Key: 272749115
• Report Number: 8030965-2021-05687
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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: 06/15/2021
• 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