MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VA-LCP DISTAL RADIUS; PLATE, FIXATION ,BONE

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Malunion of Bone (4529); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: andersenm.F., landgren m., schmidt l.B., hassani g., (2022) complications associated with anterior plate fixation of distal radial fractures: a retrospective study of 599 patients, journal of hand surgery (european volume) 0(0), pages 1¿6 (denmark).This retrospective aims to investigate risk factors; whether age, ao/ota fracture type or surgeon¿s experience had an impact on the incidence of postoperative complications.Between january 2016 and december 2018, patients aged 18 years and older who underwent primary surgery for a displaced drf and who were treated with an alp were reviewed.Of the 691 consecutive surgically treated patients, we excluded four patients who had surgery at a different hospital, four patients with a previous ipsilateral wrist fractures, two patients with inadequate radiographs, and 20 patients with incorrect coding who did not have a drf.Further, 37 patients were excluded due to other fixation methods than alp.Thirteen patients had deceased, and eight patients (tourists and emigrants) were lost to follow-up.603 acute drfs in 599 patients in the statistical analyses were included.The mean age was 61 years (19 to 93), and 79% were women.To limit bias caused by diverse plating systems, only our department¿s most frequently used locking plate was reviewed (2.4-mm variable angle lcp distal radius plates; depuy synthes, west chester, pa, usa).All patients had a minimum of two follow-up visits after surgery.The mean follow-up was 2.5 years (1 to 4).Thirteen patients had deceased and these deaths are noted in the follow-up data only.Reported complications: major postoperative complications in 49 patients: -complications related to hardware leading to removal (plate and/or screws): (9) pain and reduced rom (9) intra-articular screw (2) dorsal screw penetration, only one patient with extensor tenosynovitis was observed secondary to dorsal screw penetration.(2) dorsal penetration of the shaft, -13 malreduction or loss of reduction -2 extensor tendon ruptures (233 and 231 days postoperative) -1 flexor tendon ruptures (322 days postoperative), all had a prominent plate position anterior to the watershed line (soong grade 1), but none were distal and anterior to the volar rim (soong grade 2).-3 deep infection or osteomyelitis.-1 nonunion.-1 peri-prosthetic fracture.Minor postoperative complications in 17 patients -10 transient neuropraxia, none of these required a splint -3 carpal tunnel syndrome, treated without surgery -3 tendon irritation (tenosynovitis).-2 de quervain¿s tenosynovitis.-2 superficial infection.-2 wound-related problem (hypergranulation or hypersensitivity of the scar tissue) -1 complex regional pain syndrome -plate prominence evaluated as the soong grade was 228 grade 0, 354 grade 1 and 21 grade 2.-forty-four patients had dorsal screw penetration.Secondary surgery after anterior locking plate fixation in 603 distal radial fractures: -28 implant and/or screw removal.-8 carpal tunnel release.-7 refixation.-4 wound debridement.-3 tendon transfer.-3 total wrist fusion.-1 de quervain¿s release.-1 acute fasciotomy.-1 correction osteotomy.This report is for unknown synthes 2.4-mm variable angle lcp distal radius plates.A copy of the literature article is being submitted with this medwatch.This report involves one unk - plates: va-lcp distal radius.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.This report is for unknown plates: va-lcp distal radius/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.

• Brand Name: UNK - PLATES: VA-LCP DISTAL RADIUS
• 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: 15446343
• MDR Text Key: 300154055
• Report Number: 8030965-2022-07032
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 09/19/2022
• 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: 08/26/2022
• 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