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

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: 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.(b)(4).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: mereau, t.M.And ford, t.C.(2006), nitinol compression staples for bone fixation in foot surgery, journal of the american podiatric medical association, vol.96 (2), pages 102-106 (usa).The aim of this retrospective study is to review the use of niti compression staples to detemline whether they are comparable to other methods of fixation.A total of 27 patients (31 feet) underwent arthrodesis or an osteotomy fixated using compression staples.Osstaples (bme, san antonio, texas) were used in 18 feet and a competitor device was used in 13 feet.Minimun follow-up was 3 months.The mean follow-up period was unknown.The following complications were reported as follows: 1 patient showed an asymptomatic broken 25 x 22-mm osstaple at the talonavicular joint at 5 months after surgery (fig.4).In 2 cases, the lateral cortex fractured 6 and 10 weeks after surgery.Both patients remained free of pain, and the fixation appeared to be radiographically stable and healed at 9 and 14 weeks.This report is for an unknown synthes bone staples.This is report 1 of 2 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: 11496096
• MDR Text Key: 246495149
• Report Number: 2939274-2021-01327
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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: 02/18/2021
• 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