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

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 09/07/2017

Event Type  Injury  

Event Description

It was reported that patient had a left shoulder labral repair on (b)(6) 2016.Patient was doing well but in (b)(6) 2016 she started to complain of constant pain.A mri was performed which showed anchor had popped out.It was two-thirds of the way out.As a result, a revision surgery was done to remove the loose anchor.Patient was reported to be doing well in post-operative checks.The report mentions a footprint anchor which we have found is a shoulder repair technique.Other anchors can be used in this technique, not necessarily a smith & nephew.It was on (b)(6) that we found out that an actual smith & nephew footprint anchor was used in this patient.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.Without evaluation of the explanted anchor and/or radiological imaging, the root cause of the anchor loosening cannot definitively be determined, although excessive weight bearing (on crutches just 2 months post left bicep tenodesis) was likely a contributing factor.The patient impact was the reported pain and revision procedure.The patient reportedly still experiences pain s/p adhesion lysis and subacromial decompression secondary to a type ii ac which is commonly seen in the type of traumatic injury the patient initially sustained (with an outstretched hand/arm).

• Brand Name: UNKNOWN - MANSFIELD
• 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 drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8336023
• MDR Text Key: 136037481
• Report Number: 1219602-2019-00190
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 03/26/2019
• 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): Other
• Patient Age: 40 YR