MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203708

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when during a rotator cuff procedure with a healicoil rsb sa 5.5mm w/1 ut & 1 ub blk, one suture unloaded and the other suture was still loaded through the implant and was used to tie the cuff down.The issue was solved with the same device and it is unknown if there was a delay.No patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Even though one of the sutures unloaded, the procedure was successfully completed with the same device and did not require any intervention.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11404611
• MDR Text Key: 234439198
• Report Number: 1219602-2021-00427
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: 00885554031423
• Combination Product (y/n): N
• PMA/PMN Number: K123393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 72203708
• Device Lot Number: 2062981
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR