MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 2.4 MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATES/SCREWS; BONE PLATE

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/12/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: bachoura, a.Et al (2022), flexor tendon attritional ruptures following distal radius volar plate fixation, the journal of hand surgery, vol.Xx (xx), pages 1.E1-1.E9 (usa).The purpose of this study was to investigate patient and radiographic factors that may correlate with the time to flexor tendon rupture following operative fixation.During the study period, among 406 patients who underwent deep hardware removal and/or removal of wrist prosthesis, 31 patients (7 male and 24 female) with flexor tendon rupture were analyzed and included in the study.Mean age at the time of hardware removal and flexor tendon management was 66 years (n=31).Among these, volar plate being used is from synthes in 18 patients.The following complications were reported as follows: a 56-year-old female patient, with synthes small fragment 3.5mm titanium t-plate, had complete flexor pollicis longus (fpl) rupture.A 75-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete flexor pollicis longus (fpl) rupture, partial flexor digitorum profundus (fdp) index rupture.A 55-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture.A 58-year-old female patient, with synthes volar distal radius t-plate, had complete fpl rupture.A 53-year-old female patient, with synthes 2.4mm juxta articular plate, had complete fpl rupture.A 72-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture, partial flexor digitorum superficialis (fds) index and fdp index ruptures.A 72-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture, partial fdp index rupture.Patient 16: a male patient, with synthes 2.4mm juxta articular plate, had partial fpl rupture, complete fdp index rupture.A 76-year-old male patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture.A 48-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture, complete fds index and fdp index ruptures.A 60-year-old female patient, with synthes volar column plate, had complete fpl rupture, partial fdp index rupture.A 56-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture.A 51-year-old male patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture, partial fds index rupture.A 76-year-old female patient, with synthes volar column plate, had partial fpl rupture, complete fdp index rupture.A 56-year-old male patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture.A 58-year-old female patient, with synthes 2.4mm juxta articular plate, had complete fdp index rupture.A 69-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture, partial fdp index rupture.A 62-year-old female patient, with synthes 2.4mm va lcp 2-column, had complete fpl rupture.This report is for an unknown synthes volar distal radius plates/screws.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: 2.4 mm va-lc.This is report 5 of 10 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D1, d2, d3, d4, g4-510k: this report is for an unk - constructs: 2.4 mm va-lc/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - CONSTRUCTS: 2.4 MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATES/SCREWS
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17143986
• MDR Text Key: 317323583
• Report Number: 8030965-2023-07564
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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: 05/30/2023
• 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