MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK ST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72205138

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that during an unspecified arthroscopy, the healicoil pk anchor tip pulled out while been deployed.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference case-(b)(4).

Event Description

It was reported that during an unspecified arthroscopy, the healicoil pk anchor tip pulled out while been deployed.The procedure was completed with a s+n back up device into the same bone hole since no void holes were left.There was no surgical delay and no further complications were reported.

Manufacturer Narrative

H2: additional information in b5.H10: 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.As there was no void left inside the patient, the same device was implanted as a backup device in the same bone hole with no complications.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 KNOTLESS PK ST
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18035314
• MDR Text Key: 326965114
• Report Number: 1219602-2023-02106
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205138
• Device Lot Number: 2100404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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