MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DHS 135 DEGREE STANDARD BARREL; APPLIANCE, FIXATION, NAIL

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: dhs/dcs/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.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

This report is being filed after the review of the following journal article: arshad, z.Et al (2021), dynamic hip screw fixation of subtrochanteric femoral fractures, european journal of orthopaedic surgery & traumatology, vol.Xx (xx), pages 1-7 (united kingdom).The aim of this retrospective study is to compare some peri-operative outcome measures of a group of patients with subtrochanteric fractures treated with either an imn or a dhs construct.Between october 2014 to may 2019, a total of 86 patients were included in the study classifying them into two treatment groups; imn and dhs.74 patients (14 male and 60 female) with a median age of 84 years received an imn and 12 patients (3 male and 9 female) with a median age of 85 years received a dhs.All imns used were long (300¿460 mm) intramedullary titanium trochanteric fixation nails (synthes) with proximal lag and distal locking screws.In those patients receiving a dhs, a dynamic hip screw system (synthes) with a standard 38 mm, 135° barrel was used along with a dynamic compression plate containing between 5 and 10 holes through which 4.5-mm cortical screws were inserted.The mean follow-up period was unknown.The following complications were reported as follows: imn group: 3 patients died at the hospital.3 patients died at 30 days post-op.18 patients died at 1-year post-op.The imn group had a mean blood loss of 1028.74 (909.42¿1148.07).40 patients required blood transfusion in the five days following their operation.8 patients required blood transfusion > 2 units.2 patients had deep infection requiring washout.1 patient required reoperation due to initial sub-optimal fixation and positioning of the nail.4 patients had implant failure due to proximal screw cut out requiring reoperation.Dhs group: 1 patient died at the hospital.2 patients died at 30 days post-op.3 patients died at 1-year post-op.The dhs group had a mean blood loss of 776.19 (540.69¿995.90).1 patient had implant failure due to periprosthetic fracture requiring reoperation.4 patients required blood transfusion.This report is for an unknown synthes tfn long constructs, unknown synthes tfn lag screws, and unknown dhs 135° standard barrel constructs.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: 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, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - CONSTRUCTS: DHS 135 DEGREE STANDARD BARREL
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12342755
• MDR Text Key: 267279334
• Report Number: 8030965-2021-06855
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention