MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72200750

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.

Event Description

It was reported that the patient had swelling and allergic reaction after a procedure with an unidentified twinfix anchor.

Manufacturer Narrative

Additional information made available after initial submission.

Event Description

On (b)(6) 2011, the patient had a shoulder procedure to fixate the labrum of the left shoulder.No complications or patient injury were reported after the initial procedure.It was identified via a follow up that in (b)(6) 2015 the patient fell on the affected shoulder, causing renewed pain and movement restriction due to alleged implant loosening.Pain has persisted since patient reinjury.No revision surgery has been planned to date.

Manufacturer Narrative

After lot number was reported, a review of the sterility records was conducted.The product was sterilized per specifications.All process parameters were confirmed to be within specification.No abnormalities were reported with this product during manufacture.Further investigation is not warranted at this time.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• 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 w william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6042310
• MDR Text Key: 57916185
• Report Number: 1219602-2016-01197
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2016

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 Expiration Date: 08/30/2015
• Device Catalogue Number: 72200750
• Device Lot Number: 50347151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2016; 03/06/2017
• 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): Other
• Patient Age: 41 YR