MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA PK 5.5MMCOBRD WHTBL COBRD BL BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202601

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

This patient received the device for repair of the rotator cuff.The patient had a repeat tear after a repair of a large cuff tear.The relationship of the device and procedure to the repeat tear cannot be ruled out by the treating investigator.No treatment with medication or additional procedures has been reported.Additionally, the patient did not experience any prolonged hospitalization, no medical or surgical interventions, and no persistent or significant disability or incapacity.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated that the date of the initial surgery was (b)(6) 2015.The surgeon indicated that there may be a "possible" relationship to the study device.The patient was compliant with the surgeons instructions, after the initial repair with regards to modified activities, and physiotherapy.A left shoulder x-ray pre-operatively (based on x-ray from (b)(6) 2014) demonstrated no fracture, arthritic change or abnormality.The patient has reported that he is improving in terms of pain and range of motion, with occasional throbbing at the end of the day.He is tolerating modified duties at work well and is following physiotherapy accordingly.

Manufacturer Narrative

A review of the device history record was performed which confirmed no inconsistencies.(b)(4).

• Brand Name: TF ULTRA PK 5.5MMCOBRD WHTBL COBRD BL BL
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5060613
• MDR Text Key: 25818102
• Report Number: 1219602-2015-00953
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093228
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 72202601
• Device Lot Number: 50436168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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 Age: 52 YR