MAUDE Adverse Event Report: DSM BIOMEDICAL, INC. ARTHREX DX REINFORCED MATRIX; SURGICAL MESH

Model Number 30031-02

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Review of device history files for final product lot 7002099 and intermediate material lots 8002159 (pn 6445-61) and e8176 (pn 6199-04) show no ncr that could cause failure mode.Device could not be returned.Root cause could not be determined and dhf review shows no ncr/deviation from process that could lead to failure mode.

Event Description

It was reported that the arthrex dx device (abs-30002) was implanted.After 6 weeks, a synovialitis developed in the patient.A revision surgery to an inverse prothesis was necessary.

• Brand Name: ARTHREX DX REINFORCED MATRIX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DSM BIOMEDICAL, INC.; 735 pennsylvania drive; exton PA 19341
• Manufacturer (Section G): DSM BIOMEDICAL, INC.; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: alice cousens ; 735 pennsylvania drive; exton, PA 19341
• MDR Report Key: 9240625
• MDR Text Key: 167834196
• Report Number: 2530154-2019-00007
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 30031-02
• Device Catalogue Number: 30031-02
• Device Lot Number: 7002099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention