MAUDE Adverse Event Report: ARTHREX, INC. ALLOSYNC¿ CB DBM PUTTY, 10CC; CALCIUM SULFATE PREFORM PELLET

Model Number	ALLOSYNC¿ CB DBM PUTTY, 10CC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was 3 weeks out from acl tunnel bone grafting with dowels procedure which occurred on (b)(6) 2021.That was the first stage of a revision from an acl procedure from years ago.During the first follow up a week post op on (b)(6) 2021 the patient had mild pain and moderate swelling.On (b)(6) the patient went to the emergency department reporting the swelling and pain has increased.On (b)(6) 2021 he came in to see the doctor and the exam reported active drainage over the incision and was diagnosed with an infection.It was determined all of the implanted items will need to be removed including the allosync putty and two dowels.Additional information: the dowels (not an arthrex item) were reamed out along with the putty.The only arthrex product removed during this procedure was the abs-2014-10.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to a patient-specific event.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(6).

• Brand Name: ALLOSYNC¿ CB DBM PUTTY, 10CC
• Common Device Name: CALCIUM SULFATE PREFORM PELLET
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19357818
• Report Number: 1220246-2024-03559
• Device Sequence Number: 3727628
• Product Code: MQV
• UDI-Device Identifier: 10889981153694
• UDI-Public: 10889981153694
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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 Expiration Date: 11/28/2021
• Device Model Number: ALLOSYNC¿ CB DBM PUTTY, 10CC
• Device Catalogue Number: ABS-2014-10
• Device Lot Number: 172787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown