MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BME SPEED(TM) IMPLANT KIT 9 X 10 MM; STAPLE,FIXATION,BONE

Model Number SE-0910

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

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.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, the patient was implanted with a speed compression implant kit staple cci.During that time, it was determined through a patient chart review that the patient had a nickel allergy.Surgeon then determined that the cci should be removed.There is no surgical delay.Procedure was successfully completed.Patient status is unknown.This report is for one (1) bme speed(tm) implant kit 9 x 10 mm.This is report 1 of 1 for (b)(4).

• Brand Name: BME SPEED(TM) IMPLANT KIT 9 X 10 MM
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10935699
• MDR Text Key: 219323023
• Report Number: 2939274-2020-05413
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020111
• UDI-Public: (01)00810633020111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE-0910
• Device Catalogue Number: SE-0910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• 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