MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Skin Irritation (2076); Tissue Damage (2104); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking compression plate and screw systems/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.

Event Description

This report is being filed after the review of the following journal article: schwarz n., et al (2013) technical complications during removal of locking screws from locking compression plates: a prospective multicenter study,eur j trauma emerg surg volume 39, pages 339¿344 (austria).This study aims to systematically collect data on implant removal surgery in patients who had undergone fracture fixation with lcps, with the focus on evaluating the occurrence of intraoperative technical complications and the techniques associated with resolving these events.Between september 2009 and november 2010, a total of 205 patients who were scheduled for implant removal surgery after a healed fracture of the femur, tibia, humerus, distal radius, or clavicle previously treated with internal fracture fixation using an lcp and locking screws were prospectively included in the study.Implant removal surgery was performed in 204 of the 205 patients.The mean age of the study population was 46 years [standard deviation (sd): 15 years), with 55 % (n = 113) of the patients being female.Implants were removed 14.7 months after fracture fixation surgery (range 2.6¿89.9 months) the following complications were reported as follows: 96 patients had implant removal due to skin and soft tissue irritation.(one of the main medical indications for implant removal) 82 patients had implant removal due to pain.(one of the main medical indications for implant removal) 57 patients had implant removal due to uncomfortable feeling due to implant.(one of the main medical indications for implant removal) 20 patients had implant removal due to meteosensitivity.17 patients had implant removal due to only routine removal, no other indication.14 patients had implant removal due to impairment of mobility.9 patients had implant removal to afraid of refracture or future complaints.5 patients had implant removal due to carpal tunnel syndrome.4 patients had implant removal due to paresthesia.4 patients had implant removal due to young patients age.3 patients had implant removal due to doctors advise.3 patients had implant removal due to simultaneous revision surgery.7 patients had implant removal due to intraarticular position of the implant.2 patients had implant removal due to suboptimal implant position.3 implant removal : other indication.Apart from the technical complications , nine non-technical complications occurred in eight patients during or after implant removal surgery.There were two wound infections and one postoperative hemorrhage.One patient experienced compartment syndrome with paresis of the peroneal nerve, requiring fasciotomy.One patient had persistent paresthesia in the upper extremity and two patients had pain in the forearm which was not present before surgery and which did not recover within the 3-month observation period.A total of 1,462 locking screws were removed from 204 lcps (average: 7 screws per plate; range 1¿16).In one case where the locking screw could not be removed, the plate was cut from the side to access the screw hole.In another patient, the screw was pulled out by bending the plate; however, this caused an iatrogenic fracture to the bone which required internal fixation with a new plate.( the iatrogenic fracture of the humerus during implant removal was one of the nine non-technical complications occurred in eight patients during or after implant removal surgery.Which was directly associated with a technical complication) 3 patients had implant removal due to screw loosening.Altogether, 204 lcps were removed completely, whereas 21 screw shafts had to be partially left in the patient.Drilling off the screw head was applied to 3 of the screws with a damaged thread.(among 78 screws which could not be removed with standard screwdrivers and required the use of additional instruments in 41 patients) to remove the remaining screw shafts, additional techniques, such as drilling of the screw shaft (3 screws), the use of a gouge (3 screws), or the use of a hollow reamer (4 screws), were applied to resolve the reported technical complications.(among 78 screws which could not be removed with standard screwdrivers and required the use of additional instruments in 41 patients where) pre-drilling of the locking screw recess (7 screws) was required in some cases in order to attach the extraction screw.24 patients had screws that could not be loosened because they were jammed in the lcp.24 patients had screws with a damaged recess in which the screwdriver turned freely.3 patients had damaged screw thread.3 patients had broken screw heads were reported.1 patients had broken screw shafts were reported.Drilling off the screw head was applied to 29 screws that were jammed and/or had a damaged recess.(among 78 screws which could not be removed with standard screwdrivers and required the use of additional instruments in 41 patients) this report is for an unknown synthes locking compression plate and screw systems.It captures the reported events of compartment syndrome, nerve injury, infection, medical device site reaction, medical device site joint movement impairment, paresthesia, carpel tunnel syndrome, joint range of motion decreased, pain, soft tissue injury, skin irritation, medical device removal and surgical intervention.This is report 1 of 10 for (b)(4).This literature article involves total 62 impacted devices.Additional devices are reported under related complaints (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• 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: 10511331
• MDR Text Key: 213859616
• Report Number: 8030965-2020-06710
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 08/19/2020
• 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
• Patient Outcome(s): Required Intervention