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

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: uchiyama y., et al (2020) locking versus nonlocking superior plate fixations for displaced midshaft clavicle fractures: a prospective randomized trial comparing clinical and radiographic results, journal of orthopedic science xxx (xxxx) xxx, pages 1-6 (japan) this study aims to prospectively compare the clinical and radiographic outcomes between locking and nonlocking superior plate fixation for displaced midshaft clavicle fractures (dmcf).From january 2007 to august 2015, 102 consecutive patients with dmcf were included in this randomized trial.A total of 102 patients were enrolled in the study.Patients were assigned into either the locking or the nonlocking superior plate fixation groups via central computerized block randomization.Ninety patients were randomized to each of group l and group n, and 12 were excluded because of under 18 years.At 10 months after surgery, three patients in group l and four patients in group n did not attend the final follow-up.Therefore, the final analysis included 42 patients (33 males and 7 females) age 45.9 years in group l and 41 patients (31 males and 8 females) age 43.6 years in group n.During fixation, a 3.5-mm titanium locking compression plate (lcp) reconstruction plate (depuy synthes, west chester, pa) was positioned and fixed on the anterosuperior surface of the clavicle, starting medially, using either locking screws and holes (in group l) or nonlocking screws and holes (in group n).Each lcp had 5-7 holes.To ensure rigidity, the lcp reconstruction plate was then fixed with two and three bicortical screws on the proximal and/or distal sides of the fracture, respectively, using either locking or nonlocking screws according to group.Total follow-up duration for l group is 14.3months range 10 20 months and and 15.6 range 10-25 months in n group.The following complications were reported as follows: postoperative complications in group l: 3 patients with peri-implant fractures.2 delayed bone union.Postoperative complications in group n: 1 non-union and plate bending.1 patient with peri-implant fractures.11 delayed bone union.1 bent plate this report is for an unknown synthes a 3.5-mm titanium locking compression plate (lcp) reconstruction plate.This report is for (1)unk - plates: 3.5 mm lcp reconstruction.This report is 6 of 6 for (b)(4).

Manufacturer Narrative

(b)(4).Additional narrative: 510k: this report is for an unk - plates: 3.5 mm lcp reconstruction /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 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 LCP RECONSTRUCTION
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12586266
• MDR Text Key: 283955267
• Report Number: 8030965-2021-08448
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Patient Sequence Number: 1