MAUDE Adverse Event Report: SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC DYNAFORCE IS A NITINOL SUPERELASTIC BONE STAPLE; STAPLE, FIXATION, BONE

Catalog Number 7118-1818KT

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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.Brand name: dynaforce is a nitinol superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j employee.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

It was reported that on an unknown date, a patient thought that she might be having an allergic reaction to a plate after her surgery.She had a crossroads extremity systems plate implanted approximately 14 weeks prior to (b)(6) 2022.The implants will not be recovered.No further information is available.This report involves one dynaforce is a nitinol superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.This is report 1 of 2 for (b)(4).

• Brand Name: DYNAFORCE IS A NITINOL SUPERELASTIC BONE STAPLE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16053018
• MDR Text Key: 306189251
• Report Number: 3020584246-2022-00063
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7118-1818KT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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
• Treatment: IMPLANT, DYNABUNION PLATE 18MM - LEFT
• Patient Outcome(s): Required Intervention
• Patient Sex: Female