MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE; PLATE, FIXATION, BONE

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Loss of Range of Motion (2032); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article lee, s.K., ma, s.B., kim, w., and choy, w.S.(2021) a comparison of pronator quadratus preservation and dissection approaches for volar plating of comminuted intra-articular distal radius fracture, annals of plastic surgery, vol.86 (04) pages 412-420 (south korea).The aim of this retrospective study was to assess the efficacy of pronator quadratus (pq) preservation for comminuted intra-articular fractures and to evaluate the healed pq during hardware removal surgery.Between january 2014 to march 2019, a total of 86 patients (group p, n= 42 patients with a mean age of 61.1 (24¿84 years); group d, n= 44 patients with a mean age of 59.4 (22¿92 years) who underwent a procedure using the variable-angle locking compression plate two-column volar distal radius plate (synthes, oberdorf, switzerland) and distal volar radius plate (a competitive device).An unknown number of patients with synthes variable-angle locking compression plate two-column volar distal radius plate underwent implant removal due to: group p: n= 2 patients experienced tenosynovitis n= 8 patients experienced discomfort n= 32 patients experienced non-clinical matters group d: n= 6 patients experienced tenosynovitis n= 2 patients had injured flexor tendon n= 10 patients experienced discomfort n= 3 patients developed prominence of plate n= 23 patients experienced non-clinical matters intraoperative evaluation during hardware removal surgery: n= 2 patients in group d were not able to actively flex their thumb interphalangeal joint at 7 months and 10 months postoperatively and were diagnosed as having ruptured flexor pollicis longus (fpl) with an additional ultrasonography.They underwent tendon reconstruction using palmaris longus interposition graft combined with hardware removal surgery.A copy of the literature article is being submitted with this medwatch.This report involves one unk - plates: 2.4 mm variable angle lcp volar rim distal radius plate.This is report 1 of 2 for (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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown plates: 2.4 mm variable angle lcp volar rim distal radius plate /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17161797
• MDR Text Key: 317475660
• Report Number: 8030965-2023-07667
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• 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