MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/14MM; PLATE,FIXATION,BONE

Model Number	04.501.024.05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional 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 as no product was received.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 or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of five (5) titanium matrixrib locking screw, one (1) titanium matrixrib pre-contoured plate and three (3) titanium matrixrib universal plate due to infection that have stemmed from the soft tissue wound breakdown near the site of the implants on the left rib.Originally, the implants were implanted on (b)(6) 2019.The rib fractures was healed, hardware was removed, and the surgical site was irrigated/debrided.The procedure was successfully completed, and patient status was satisfactory.This complaint involves nine (9) devices.This is the report of (1) 2.9 mm ti matrixrib locking screw self-tapping/14 mm.This is report 01 of 09 of (b)(4).

• Brand Name: 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/14MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9660497
• Report Number: 2939274-2020-00607
• Device Sequence Number: 3319905
• Product Code: HRS
• UDI-Device Identifier: 20887587017225
• UDI-Public: (01)20887587017225
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.501.024.05
• Device Catalogue Number: 04.501.024.05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 85