MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device evaluated by mfr, manufacture date: 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: hau, r.Et al (2000), which implant for proximal femoral osteotomy in children? a comparison of the ao (asif) 90 fixed-angle blade plate and the richards intermediate hip screw, journal of pediatric orthopaedics, vol.20, pages 336-343 (australia).The purpose of this study was to establish clinical and radiologic outcomes, to establish an over-all incidence of complications, and to establish relative indications and contraindications for each device.Between february 1994 and february 1998, a total of 132 patients (76 male and 56 female) were included in this study.These patients were divided into 2 groups, the first group were treated with the intermediate hip screw (23 male and 21 female) with a mean age of 8.5 (range 4-18 years) and a mean follow up of 32 months (range 12-54).The other group were treated with a fixed angle blade plate (53 male and 35 female) with a mean age of 10.1 (range 4-19 years) and a mean follow up of 25 months (range 12-54).The majority of the valgus osteotomies were fixed with hip screws, but all of the pure derotational osteotomies were fixed with blade plate.The following complications were reported as follows: 1 patient had peroneal nerve palsy (patient 2).1 patient had peroneal nerve palsy and superficial wound infection (patient 3).1 patient had superficial wound infection after elective removal of implant (patient 4).1 patient had superficial wound infection (patient 5).1 patient had deep wound infection after removal of implant (patient 6).1 patient fractured through the most distal screw hole after elective removal of implant (patient 8).1 patient fractured through neck of the femur day 2 postop (patient 9).(b)(6) girl in the blade plate group revealed a displaced intertrochanteric fracture of the femur in the post op radiograph (patient 9).(b)(6) male who had an uneventful recovery from the index osteotomy (patient 8).This report is for an ao (asif) fixed-angle blade plate.This is report 1 of 6 for (b)(4).Due to a limit of impacted products per complaint, this complaint will be continued under complaint (b)(4).

Manufacturer Narrative

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.Updated additional information provided for reporting.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

Update: this impacted product captures a patient who had peroneal nerve palsy.(patient 2).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8620784
• MDR Text Key: 145406309
• Report Number: 8030965-2019-64103
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention