MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown proximal femoral nail (pfn)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: saudan, m.Et al (2011), pertrochanteric fractures: is there an advantage to an intramedullary nail? a randomized, prospective study of 206 patients comparing the dynamic hip screw and proximal femoral nail, journal of orthopaedic trauma, vol.16 (no.6), pages 386-393 (switzerland).The aim of this prospective computer-generalized randomization study is to compare the results between a sliding compression hip screw and an intramedullary nail in the treatment of pertrochanteric fractures.Between march 1998 to july 2000, a total of 206 patients (46 male and 160 female), over the age of 55 years, were randomly divided into two groups.106 patients were treated with a dynamic hip screw (dhs, synthes-stratec, oberdorf, switzerland) and 100 patients were treated with a proximal femoral nail (pfn, synthes-stratec, oberdorf, switzerland).Follow-up evaluation was performed at three, six, and twelve months postoperatively.The following complications were reported as follows: in dhs group: 17 deaths (4 in-hospital deaths, 13 patients died during one-year follow-up).1 patient needed reoperation for hip prosthesis.1 patient needed reoperation for removal of the implant and/or debridement.10 patients developed local wound complication during hospitalization, characterized by wound drainage, hematoma formation, or delayed healing.24 patients had urinary infection.7 patients had respiratory problem.9 patients had a cardiovascular problem.4 patients had decubitus.1 patient had pulmonary embolism.1 patient had deep vein thrombosis.2 patients had gastrointestinal problem.1 patient had neurologic problem.1 patient had early infection at six weeks postoperatively.Unknown number of patients had persistent pain localized it to the lateral thigh or groin with a pain score of 1.31 ± 0.63.72 patients had blood transfusion.The jensen or social function is 2.65 ± 1.14.The mean mobility score is 5.07 ± 2.97.1 patient had hip screw cut-out.In pfn group: 20 deaths (4 in-hospital deaths, 16 patients died during one-year follow-up).3 patients needed reoperation for hip prosthesis.3 patients needed reoperation for removal of the implant and/or debridement.11 patients developed local wound complication during hospitalization, characterized by wound drainage, hematoma formation, or delayed healing.34 patients had urinary infection.7 patients had respiratory problem.5 patients had cardiovascular problem.3 patients had decubitus.1 patient had pulmonary embolism.1 patient had deep vein thrombosis.1 patient had gastrointestinal problem.2 patients had neurologic problem.2 patients had early infection at four weeks postoperatively.2 patients had late infection at four weeks postoperatively at eleven and fifteen months, respectively.Unknown number of patients had mid to distal thigh pain with a pain score of 1.36 ± 0.63.55 patients had blood transfusion.The jensen or social function is 2.88 ± 1.16.The mean mobility score is 4.94 ± 3.33.2 patients had hip screw cut-out.1 patient had hip pin from the pfn migrated across the hip joint into the acetabulum (nail).This report is for an unknown synthes unknown proximal femoral nail (pfn).This is report 3 of 4 for (b)(4).It captures the reported adverse events of reoperation for hip prosthesis, reoperation for removal of the implant and/or debridement, local wound complication during hospitalization, characterized by wound drainage, hematoma formation, or delayed healing, early infection, persistent pain localized it to the lateral thigh or groin.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 8683211
• MDR Text Key: 147480569
• Report Number: 8030965-2019-65120
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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: 05/13/2019
• 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