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

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient information unknown.This report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is unknown.Complainant part is not expected to be returned for manufacturer.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: agarwal s., udapudi s., gupta s.(2018) to assess functional outcome for intra-articular and extra-articular distal femur fracture in patients using retrograde nailing or locked compression plating.Journal of clinical and diagnostic research.Volume 12, number 3, pages 21 - 24 ((b)(6)).The aim of this prospective study was to determine the best functional outcome for distal third femur fracture treated by closed/open reduction using retrograde nailing or locked compression plating in respect to knee-flexion, early mobilization and fracture union and full weight bearing.Between july 2015 to june 2017, 40 patients who were treated for intra-articular and extra-articular distal femur fractures were included in the study.20 patients with 15 males and 5 females with a mean age of 39.6 years (group a) were operated with a competitor¿s supracondylar nail system for retrograde nailing, and the other 20 patients with 16 males and 4 females with a mean age of 37.4 years (group b) were operated with an unknown synthes locking compression plating.All patients were assessed using modified neer¿s criteria which assigns points for pain, function, working ability, joint movements, gross and radiological appearance.All patients were followed up at 6th week, 3 months, 6 months and 1 year postoperatively and thereafter till fracture union was noted.These complications are associated with the patients who were implanted with an unknown synthes lcp: three patients had shortening with an average 1.5 cm and could be compensated by giving a shoe raise.One case of delayed union in plating group and fracture union occurred after seven months.Two cases of mal-union, which were given physiotherapy.One patient had a fair functional outcome/modified neer¿s score (55 to 69).One patient had a poor functional outcome/modified neer¿s score (less than 55).There were four patients who complained pain at the site of distal screws and two patients who had snapping and which required screw removal after fracture healing.The article does not mention which implant (nail or plate) these complications were associated with.This report is for an unknown synthes locking compression plate.This report is for an unknown screw.This is report 3 of 3 for (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7677361
• MDR Text Key: 113658761
• Report Number: 8030965-2018-54929
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• 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