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

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Injury (2348); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown distal radius plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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: lee, j.H.Et al (2020), complications associated with volar locking plate fixation for distal radius fractures in 1955 cases: a multicentre retrospective study, international orthopaedics, pages 1-11 (south korea).This study aimed to identify the general characteristics of patients treated with vlp, analyse types and rates of complications, and compare our data with those found in the literature.From january 2008 and december 2017, a total of 1921 patients underwent vlp fixation for distal radius fractures.The mean age of patients was 60.3 ± 14.6 years (range, 18¿ 99 years).In total, 587 were male and 1334 were female.The inserted plates used were from depuy synthes distal radius system (j&j medical devices, raynham, ma, usa) for 1752 patients, the acu-loc wrist plating system (acumed, llc, hillsboro, or, usa) for 100 patients, the aptus wrist distal radius system 2.5 (medartis, basel, switzerland) for 48 patients, and the dvr crosslock distal radius plating system (zimmer biomet, warsaw, in, usa) for 37 patients.The average follow-up duration was 18.5 ± 6.3 months (range, 4¿117 months).The article did not specify which of the devices were being used to capture the following complications: tendon-related.9 patient had complications involving the flexor pollicis longus (fpl) tendon.3 patients had partial rupture or tendon adhesion managed with tenolysis.Or debridement with plate removal intra-operatively.6 patients had a complete rupture.2 patients refused further management.4 patients underwent secondary tendon surgery with plate removal resulting in one direct repair, 2 palmaris longus (pl) tendon grafts, and one 4th flexor digitorum superficialis tendon transfer.12 patients had complete extensor pollicis longus (epl) tendon rupture after volar plate fixation for drf.10 patients underwent extensor indicis proprius (eip) transfer.1 patient underwent a partial tendon graft from the extensor carpi radialis brevis.1 patient refused further management and was lost to follow-up.Nerve-related.9 patients injured palmar sensory branch of the median nerve.3 patients had complete intraoperative laceration which was subsequently repaired.3 patients developed 15 cases of crps, according to the budapest criteria.They received intensive physical and rehabilitation therapy and pharmacological treatment.36 patients had carpal tunnel syndrome (cts).3 patients had acute cts, and concomitant carpal tunnel release was performed along with volar plate fixation.13 patients complained of cts symptoms after trauma or volar plate fixation.However, the symptoms were relieved with non-operative management, indicating subacute cts.20 patients had chronic cts after injury.Of these, 14 underwent carpal tunnel release with 10 patients undergoing concomitant implant removal.Fixation- and instrument-related.5 patients had fracture displacement after plate fixation.6 cases had broken screws.3 cases of screw breakage occurred together with fracture displacement.2 cases of broken screws occurred with non-union complications.26 cases had radiocarpal joint penetration.2 cases caused by secondary joint violation with fracture displacement and articular collapse.511 wrists underwent implant removal post-operatively.388 patients underwent implant removal without clinical symptoms, resulting in only 123 patients with implant removal due to clinical reasons.Osteosynthesis-related.5 patients showed delayed union but achieved union later after clinical observation.3 patients had confirmed non-union diagnosed by ct radiogram and required secondary osteosynthesis, bone grafting, and reimplantation.Infection.83 patients required antibiotic treatment for more than one week for suspected cases of superficial infection which resulted in resolution without further intervention.2 patients required second wound revision surgery, implant exposure, and debridement followed by abundant irrigation were required, but the inserted plates were not removed.Others: 2 patients had compartment syndrome who were treated with combined fasciotomy and carpal tunnel.Release along with drf fixation with a volar plate.3 patients also had radial artery damage, which was subsequently managed with arterial repair, except for cases involving the palmar branch, which were managed intraoperatively.A 62-year-old male patient fell from a ladder causing an ao-ota type c3 distal radius fracture.With the open reduction and volar locking plate fixation, the volar tilting angle is restored by 5° on lateral post-operative x-ray; however, the reduced fracture is displaced about 12° dorsally even after locking plate fixation.At post-operative 5 months, the patient complained of a lack of flexor pollicis longus tendon function after a popping sensation.Implant removal is performed, and the ruptured flexor pollicis longus tendon is repaired with a krackow tendon repair method.A 59-year-old female patient had a distal radius fracture dorsally tilted with a separated sharp fracture fragment treated with volar open reduction and locking plate fixation.After 109 days, the extensor pollicis longus tendon ruptured over the bony spur from the initial fragment.The implant removal, spur excision, and extensor indicis proprius are transferred to the rupture extensor pollicis longus tendon.A 76-year-old female patient with an ao-ota type c1 right distal radius fracture is treated with open reduction and locking plate fixation.After 2 weeks, the reduced fracture fragment collapsed proximally, causing secondary joint penetration by two distal locking screws.Under local anaesthesia, the two screws are removed.This is report 2 of 7 for (b)(4).This report is for an unknown synthes distal radius plate.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES
• 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: 10421311
• MDR Text Key: 211081029
• Report Number: 8030965-2020-06093
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• 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