MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 07/19/2018

Event Type  Injury  

Event Description

It was reported that 16 hours after a rotator cuff repair on (b)(6) of 2019, patient had a right pneumothorax, with short of breath.This event was treated with a pigtail catheter placement, patient was hospitalized for 3 days with rest taken.Patient is recovered.Event is being reported due to the possible relationship to study procedure on the right side, but it is unrelated to the study device.

Manufacturer Narrative

Neither valid product code nor lot number were provided for the product used during treatment.No product was returned for evaluation.Physical evaluation, full investigation or definitive conclusions were limited without adequate information or product to evaluate.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use which includes recommendations, precautionary statements and instructions for proper use of product.There is no objective evidence to suggest a direct link between the symptoms and products used during the procedure.Product met specifications upon release.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: UNKNOWN
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8957663
• MDR Text Key: 156345923
• Report Number: 1219602-2019-01087
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR