MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL RADIUS VOLAR PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 2.4-mm lcp distal radius system/ juxta-articular construct/ 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.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-k, et al (2020), volar locking plate removal after distal radius fracture: a 10-year retrospective study, archives of orthopaedic and trauma surgery, pages 1-9, (south korea).This study aimed to compare characteristics of patients who underwent volar locking plate fixation with and without subsequent implant removal.Second, the rate of implant removal according to the implant position and type was investigated.Between january 1, 2008, and december 31, 2017, 806 patients with a total of 814 distal radius fractures were included in the study.A total of 252 patients had implant removal which comprised of 94 males and 158 females with a mean age of 50.8+/- 14.0 years.A volar locking plate fixation for distal radius fractures was performed using a modified henry approach to the fractured distal radius in-between the flexor carpi radialis and the tendons of the brachioradialis.Regarding the inserted volar locking plate, only 1 manufacturer (depuy synthes) was used, but 5 different types of plates were used depending on the fracture patterns.The plates used were the unknown synthes 3.5-mm locking compression plate (lcp) t-plate, unknown synthes 2.4-mm variable angle lcp (va-lcp) two-column volar distal radius plate, unknown synthes 2.4-mm lcp distal radius system /extra-articular, unknown synthes 2.4-mm lcp distal radius system /juxta-articular, and unknown synthes 2.4-mm va-lcp volar rim distal radius plate.Complications were reported as follows: 186 patients underwent implant removal without clinical symptoms after bony union.13 patients underwent implant removal due to carpal tunnel syndrome.11 patients underwent carpal tunnel release together with implant removal.13 patients underwent implant removal in combination with removal of other implants.12 patients underwent removal due to unclear source of discomfort or pain.3 of these patients complained of persistent pain even after implant removal.8 patients underwent removal due to foreign body sensation.6 patients had newly developed postoperative pain with subsidence during outpatient follow-up after implant removal.5 patients complained of numbness or tingling sensations along the median nerve or around the operative scar after implant removal.This report is for the unknown synthes 2.4-mm lcp distal radius system /juxta-articular construct.This is report 2 of 5 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL RADIUS VOLAR PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12563243
• MDR Text Key: 274735225
• Report Number: 8030965-2021-08266
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 11/03/2021
• 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