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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Excessive Tear Production (2235)

Event Date 08/11/2017

Event Type  Injury  

Event Description

It was reported that patient had a recurrent left rtc tear that was treated with a revision surgery.The event still ongoing.

Manufacturer Narrative

Neither valid lot number or product code were reported.Clinical details were quite limited.No product was returned, therefore physical evaluation, full investigation or definitive conclusions were impossible.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.No further actions were pursued at this time.If objective evidence or 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8628793
• MDR Text Key: 145674117
• Report Number: 1219602-2019-00584
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR