MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 4MM HXC-STERILE; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Model Number 311.060.01S

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Expiration date and lot number unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 (b)(6) 2017, a hardware removal of rapid resorbable strut plate was performed due to infection.There was an unknown allegation against the battery pack-sterile for battery powered driver.On an unknown date, the patient presented with fever and infection at the surgical site.The parents admitted allowing their dog to lick the wound site on babies head that probably caused the infection.Initially, the patient had a sagittal synostosis procedure on (b)(6) 2017.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.This complaint involves one (1) device.This report is 3 of 5 for (b)(4).

• Brand Name: TAP F/1.5MM RESORBABLE CORTEX SCR/(SLF-DRLG) 4MM HXC-STERILE
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8755705
• MDR Text Key: 149922633
• Report Number: 2939274-2019-58983
• Device Sequence Number: 1
• Product Code: HBG
• UDI-Device Identifier: 10887587035840
• UDI-Public: (01)10887587035840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153587
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.060.01S
• Device Catalogue Number: 311.060.01S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• 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
• Patient Age: 6 MO