MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN PEEK SUTURE ANCHOR; STAPLE, FIXATION, BONE

Catalog Number UNKNOWN

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

Patient Problem Malunion of Bone (4529)

Event Date 02/28/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Literature: therapeutic effect observation of modified arthroscopic double-endobutton latarjet procedure for treatment of recurrent anterior shoulder dislocation in epileptics.

Event Description

It was reported that on literature review, "therapeutic effect observation of modified arthroscopic double-endobutton latarjet procedure for treatment of recurrent anterior shoulder dislocation in epileptic", 2 patients showed obvious displacement of bone mass after surgery with a twinfix.This healed again after conservative treatment.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No product identification information was provided and thus a manufacturing record review, instructions for use review, and risk management review could not be conducted.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN PEEK SUTURE ANCHOR
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11571000
• MDR Text Key: 242301937
• Report Number: 1219602-2021-00675
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention