MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE,FIXATION,NAIL

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

Patient Problems Bone Fracture(s) (1870); Weakness (2145); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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.(b)(4).

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: poigenfürst, j., hertz, h., hofer, s.(1983), first experiences with the dynamic hip screw compared to other osteosynthesis methods, unfallchirurgie, vol 9 (2), pages 98-103 (austria).The aim of this study is to present their first experience in 30 patients treated with dynamic hip screw in order to draw some conclusions regarding the usability of this type of osteosynthesis.A total of 30 patients (9 male and 21 female) with an average age of 43 years for the males and 63 years for the females were included in the study.Surgery was performed using dhs.The mean follow-up was unknown.The following complications were reported as follows: a (b)(6) year-old male patient died.A (b)(6) year-old female patient died.5 patients had a strong positive trendelenburg¿s sign on the injured side during follow-up.Serious intraoperative complications included the greater trochanter breaking off and rotation of the head fragment when tightening the threaded bolt.In 2 patients with intertrochanteric fractures and in 1 patient with a basocervical fracture, the greater trochanter was observed to split (figures 4a to 4f).Secondary to this, the fragment has moved farther in the cranial direction and is causing a positive trendelenburg¿s sign.The dhs plate is not parallel to the femoral shaft, which may be explained by the excessive force used when placing the plate.2 patients with pauwels iii-type femoral neck fractures had rotation of the short medial fragment while fixing the dhs (figures 5a to 5f).Almost all of the patients experienced more or less severe slippage of the screws.In 2 patients, shrinkage of the femoral neck by more than 10 mm was observed with compression of the head fragment into the femoral neck stump (figures 6a to 6g).In both patients, the screw slipped out in the lateral direction without perforating the head surface.In 2 other patients, the broken-off greater trochanter rose still higher secondarily and led to considerable insufficiency induced limping.This report is for an unknown synthes dhs constructs.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10323131
• MDR Text Key: 200390559
• Report Number: 8030965-2020-05265
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 07/20/2020
• 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