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 Injury (2348); 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 construct/ unknown lot.Part and lot number 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.(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: caruso g, vitali a, del prete f (2015), multiple ruptures of the extensor tendons after volar fixation for distal radius fracture: a case report, injury, int.J.Care injured, volume 46, page s23-s27, (italy).This study presents the development of late disruption of extensor tendons secondary to protruding metalwork from the previous volar plate fixation.This is a case report on a (b)(6) year-old woman who had bicycle accident with a displaced left (non-dominant) distal radius fracture.After closed reduction a long cast was applied.3 weeks after initial reduction follow up radiographs revealed loss of reduction.An open reduction and internal fixation (orif) was performed utilizing a volar approach and the patients was implanted with an unknown volar locking compression plate.After surgery the wrist was immobilized in a cast for 10 days and then in a removable splint for 3 weeks.Follow up radiographs at 4 weeks confirmed good positioning of the plate and signs of healing.The removable splint was discontinued at 5 weeks when there was radiographic evidence of union of the distal radius fracture.The patient returned to her normal activities (dressmaker).19 months after surgery, the patient showed functional impairment of the left thumb for extensor pollicis longus (epl) injury for which she needed transposition surgery.She had a good post-operative recovery.26 months after original orif, the patient developed functional deficit of the extension of the third and fourth left finger secondary to injury of extensor tendons.Ultrasound and computed tomography scan showed dorsal protrusion of the 2 angular stability screws in lcp plate that caused a progressive wear resulting in rupture of the of the extensor digitorum communis (edc) iii and iv tendons.Another tendon transposition surgery was performed with dorsal approach while the plate was removed utilizing the original volar incision.At 5 year follow up, the patient was assessed to have a very good functional and in particular no further deficit of the extensor tendons had been observed.This report is for an unknown synthes volar locking compression plate and unknown synthes screws.This report is for one (1) unknown construct: plate/ screws.This is report 1 of 3 for (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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10375668
• MDR Text Key: 202004171
• Report Number: 8030965-2020-05717
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 08/03/2020
• 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
• Patient Age: 62 YR