MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINI TAC TI 2.0 SUTURE ANCH W/TWO DURA; STAPLE, FIXATION, BONE

Catalog Number 7210295

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after a primary surgery performed on (b)(6) 2016 where the minitac suture anchor was implanted, on (b)(6) 2017 patient started with increased pain that was treated with physical therapy, steroid injection and x-ray of hand ultrasound splint however patient was not recovered.Then, on (b)(6) 2017 a x-ray was performed and evidenced a lucency around bone anchor.Later, on (b)(6) 2017 patient started with dequervain tenosynovitis that was treated with a surgery on (b)(6) 2017.Patient was recovered.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that after a primary surgery performed on (b)(6) 2016 where the minitac suture anchor was implanted, on (b)(6) 2017 patient started with increased pain that was treated with physical therapy, steroid injection and x-ray of hand ultrasound splint however patient was not recovered.Then, on (b)(6) 2017 a x-ray was performed and evidenced a lucency aroung bone anchor.Later, on (b)(6) 2017 patient started with dequervains tenosynovitis that was treated with a left 1st dorsal compartment release on (b)(6) 2017.Patient was recovered.

Manufacturer Narrative

Event description updated.

Manufacturer Narrative

Mini tac product used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use.Instructions for use documentation is quite specific and contains specific instructions, precautionary statements and recommendations for proper use of product."bone must be adequate to allow proper placement of suture anchor.Loss of fixation or pullout of suture anchors can occur.Literature indicates the potential for magnetic resonance imaging (mri) to cause heating of metallic implants and surrounding tissue.The surgeon may wish to advise patient accordingly." complaint history review for three years prior indicated no similar allegations for the product code reported.Dhr/batch/lot review was unattainable without a valid lot number provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.There is insufficient information to conduct a risk management documentation review because the product failure mode was not reported, and devices were not returned for investigation.There was no objective evidence to suggest a direct link between the product used during the procedure and the symptom reported.If objective evidence becomes available to assist with evaluation, the complaint may be revisited.

• Brand Name: MINI TAC TI 2.0 SUTURE ANCH W/TWO DURA
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9390460
• MDR Text Key: 168438171
• Report Number: 1219602-2019-01500
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K000797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7210295
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR