MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM RECONSTRUCTION PLATE; PLATE, FIXATION, BONE

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang z, et al.(2020), comparison of the efficacy of posterior-anterior screws, anterior-posterior screws, and a posterior-anterior plate in the fixation of posterior malleolar fractures with a fragment size of = 15 and < 15%, bmc musculoskeletal disorders, volume 21, number 570, pages 1-9, (china) the purpose of this study was to investigate the efficacy of posterior-anterior (pa), anterior-posterior (ap) screws and pa plate in the fixation of pmfs with a fragment size of =15 and < 15%.From january 2015 to september 2018, 243 patients with a unilateral ankle fracture involving the posterior malleolar ankle fracture were included in the study.There were 120 males and 120 females.All patients were divided into 2 groups based on their fragment size; 136 patients had a fragment size of equal to or greater than 15 percent while 107 patients had a fragment size of less than 15 percent.After reduction of posterior malleolar fracture, posterior-anterior, anterior-posterior screws and posterior-anterior plate were used for fixation in the 2 groups.For fixation with posterior-anterior screw, 2 to 3 unknown synthes 3.5-mm cannulated screws were placed from the posterior to anterior direction; for fixation with posterior-anterior plate, an unknown synthes 3.5-mm reconstruction plate was placed from the posterior to anterior direction, and for fixation with an anterior-posterior screw, 2 to 3 unknown synthes 3.5-mm screws were placed from the anterior to posterior direction.If instability was present, a 3.5-mm lag screw was used to stabilize the syndesmosis.After surgery, all patients in each group received the same rehabilitation treatment.All patients were allowed to bear full weight at 3 months postoperative.All patients were followed up at 1, 3, 6, and 12 months after surgery and thereafter at 6-month intervals.The mean follow-up was 18.9 months.Complications were reported: (equal or greater than 15 percent fragmentation group) 2 patients had a superficial infection after surgery and were treated successfully with local dressing changes and oral antibiotic therapy.Unknown patients had dorsiflexion restriction.(less than 15 percent fragmentation group) 1 patient had superficial infection after surgery and was treated successfully with local dressing changes and oral antibiotic therapy.Unknown patients had dorsiflexion restriction.This report is for the unknown synthes 3.5-mm cannulated screw, unknown synthes 3.5-mm reconstruction plate, and unknown synthes 3.5-mm screws.This report is for one (1) unk - plates: 3.5 mm reconstruction plate.This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: 3.5 mm reconstruction plate/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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 - PLATES: 3.5 MM RECONSTRUCTION PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12693880
• MDR Text Key: 284475160
• Report Number: 8030965-2021-08963
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/25/2021
• 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