MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW; APPLIANCE, FIXATION, NAIL

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Implantation date unknown.This report is for an unk - nail head elements: dhs/dcs lag screw/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(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.

Event Description

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: fang c., et al (2015) fixing a fractured arthrodesis hip with rapid prototype templating and minimal invasive plate osteosynthesis, trauma case reports volume 1, pages 79¿83 ((b)(6)).This study presents a case report of a patient to illustrate the positive experience of rapid prototyping that enabled accurate preoperative planning, implant selection, templating, and avoidance of inference with existing hardware that is not possible with conventional.A case of an (b)(6)-year-old lady with a history of left hip tuberculosis managed with surgical fusion 16 years ago.She was admitted after a low energy fall and complained of severe mechanical pain at her left hip.X-rays revealed a mildly displaced intertrochanteric fracture at her previously fused hip.A dhs was previously used for the fusion surgery, and the lag screw which was previously fixed to the ilium bone appeared to have loosened.A ct scan was performed to confirm the location of the fracture and morphology of the fused iliofemoral segment.0.5mm cuts were obtained from the pelvis to distal femur.A 3d printed model was created from the volumetric ct data using a low-cost thermoplastic (acrylonitrile-butadiene-styrene).Two different types of long locked compression plate (lcp) for the femur were evaluated in preoperative templating.The reversed contralateral distal femur 4.5/5.0 mm lcp (depuy synthes, solothurn, switzerland) was found to offer the best fixation trajectories.A minimal invasive plate osteosynthesis (mipo) technique was used.The previous implant was retained in order to minimize surgical trauma and dissection.In total, seven locking screws were placed in the proximal fragment and five in the distal fragment.The patient was allowed to freely mobilize in bed and full weight bearing walking exercise was started two days after surgery.She was transferred to the rehabilitation unit six days after surgery and further stayed sixteen days there.On discharge, the patient was able to walk with a frame with minor assistance her modified barthel index was 49 out of 100 and lawton instrumental activities of daily living scale [14] was 6 out of 27.At two-month follow-up there was evidence of callus and fracture healing with no pain.At four months the fracture has completely united.The patient has returned to her preinjury level of function and continued to walk with a quadruped.The following complications were reported as follows: -a dhs was previously used for the fusion surgery, the lag screw which was previously fixed to the ilium bone appeared to have loosened.This report is for an unknown synthes dhs.A copy of the literature article is being submitted with this medwatch.This complaint involves one (1) device this report is for (1) viper universal poly driver.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; west chester; 19380, PA ; SZ ; 6103142063
• MDR Report Key: 10804917
• MDR Text Key: 217418315
• Report Number: 8030965-2020-08734
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• 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: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 88 YR