MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

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

Patient Problems Unspecified Infection (1930); Neuropathy (1983); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2010 to 2015.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

This report is being filed after the review of the following journal article: kucera, t., grinac, m., valtr, o., and sponer, p.(2019), mid-term outcomes of reconstruction of charcot foot neuroarthropathy in diabetic patients, acta chirurgiae orthopaedicae et traumatologiae cechoslovaca, vol 86(1), pages 51-57 (czech republic).The aim of this study was to evaluate the mid-term outcomes of the surgical reconstruction of charcot foot neuroarthropathy in diabetic patients with failed conservative treatment and indicated for a below-knee amputation.From 2010 to 2015, a total of 16 patients (7 males and 9 females) with a mean age of 65.7 years (61 to 70 years) who had failed conservative treatment underwent surgical reconstruction of inactive chronic charcot foot neuroarthropathy.Implant used was a 6.5 mm midfoot fusion bolt (depuy/synthes).Duration of fixation of the operated limb and off-loading regimen was 6 weeks, followed by a control x-ray examination, removal of the fixation and application of an individual orthosis and partial weight-bearing.The mean follow-up period was 4.7 years (2.5¿7.5 years).The following complications were reported as follows: all patients received antibiotics until their surgical wounds healed.The antibiotic treatment was extended in 10 patients to 3 weeks administered intravenously and 3 weeks administered orally.7 patients had prolonged secondary healing of the surgical wound on the outside of the foot from the ollier approach therefore this approach was not used anymore.Based on the recommendations of the midfoot fusion bolt manufacturer, the construction was supplemented with an angularly stable plate from lcp compact foot instruments (depuy, synthes) in 1 patient.However, it had to be removed due to the difficult healing in the place above the metal material.Only after the plate extraction did the surgical wounds heal completely.2 patients had formation of bone prominence between the two stabilized columns one year postop.Both patients were fully weight-bearing on the operated limb in normal footwear and there was a risk of a new ulcer development.Additional ablation of the prominent plantar skeleton from the middle part of the tarsus was performed in these patients.They had no further difficulties after ablation of the prominent skeleton.2 patients had to remove the medial midfoot fusion bolt implant due to its migration distally through the first mtp (metatarsophalangeal) joint.In neither case did the patients feel pain due to the peripheral neuropathy present.The removal was performed 3 years after the primary reconstruction in both of these patients.No further complications were noticed after the implant removal.These were the first two patients in the cohort, in which only the medial column was stabilized, in the other patients both columns were always stabilized.2 patients had damage to the skin flap associated with peripheral neuropathy after successful reconstruction.1 patient developed an infected skin ulcer after an injury by stone in the footwear.This healed conservatively.1 patient had a burn on his foot due to a heater in a trolleybus.Healing occurred after conservative treatment in this case as well.However, this man died from acute myocardial infarction 2.5 years after reconstructive cn foot surgery.This report is for an unknown synthes 6.5 mm midfoot fusion bolt (depuy/synthes) and an angularly stable plate from lcp compact foot instruments (depuy, synthes).This report is for one (1) unknown screw.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10344135
• MDR Text Key: 209146281
• Report Number: 8030965-2020-05452
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• 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: 07/28/2020
• 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