MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BONE STAPLE; STAPLE, FIXATION, BONE

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown bone staple/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: douthett, s.M.Et al.(2018), retrospective analysis of the akin osteotomy, the journal of foot & ankle surgery, vol 57, pages 38-43 (usa).The aim of this study is to investigate the frequency of disruption of the lateral cortex, osteotomy displacement, healing time, and the need for surgical revision associated with the akin procedure.From july 2011 to january 2014, a total of 132 patients (132 feet) with a mean age at surgery of 11 to 78 years underwent the akin procedure.It was performed on 66 left and 66 right feet.89 patients were treated wtih ! staple fixation method and 5 patients were treated with 2 staples fixation method.Of the 132 patients, 110 were female and 22 were male.The implants used were bme staples.The article did not specify which of the devices were being used to capture the following complications: 47 lateral cortices were disrupted intraoperatively.9 became displaced during the postoperative course.3 patients who had experienced lateral cortical hinge disruption intraoperatively required surgical revision, 1 of which had resulted from nonunion.An additional 6 patients experienced lateral cortex fracture and displacement by postoperative visit 1 (2 weeks postoperatively), 2 of whom required surgical revision.Thus, 5 patients required surgical revision, 3 who had sustained lateral cortex disruption intraoperatively and 2 who had sustained a lateral cortex fracture postoperatively.Of the 33 patients who smoked, 10 had lateral cortices that fractured intraoperatively, 3 of these osteotomies became displaced postoperatively, and 1 required surgical revision.1 patient developed a superficial infection, which resolved after a course of oral antibiotics.6 patients complained of prolonged edema.2 patients complained of neuritis of the proper branch of the medial dorsal cutaneous nerve ll of which resolved within the follow-up period.2 patients complained of generalized pain, all of which resolved within the follow-up period.2 patients were unsatisfied with the cosmetic result.This report is for an unknown synthes bme staples this is report 1 of 1 for (b)(4).

• Brand Name: UNK - BONE STAPLE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11515576
• MDR Text Key: 254939510
• Report Number: 2939274-2021-01384
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• 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: 02/22/2021
• 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