MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203378

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Rupture (2208); Unspecified Tissue Injury (4559)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a shoulder cuff repair, the healicoil anchor came out and broke when tightening.The procedure was completed with a non-significant delay using a back-up device in an additional bone hole.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).B5: event description updated.

Event Description

It was reported that during a shoulder cuff repair, the healicoil anchor came out and broke when tightening.All pieces were removed with tweezers.The procedure was completed with a non-significant delay using a back-up device in an additional bone hole.No further complications were reported.Patient status is good.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor material drawing found the storage conditions and material requirements specified for the implant material.Each lot must be accompanied by a material certificate of analysis.Based on the condition of the product material found during visual inspection, additional material testing is not required.A visual inspection found the device was returned with a broken anchor missing some of the lower threads and full of debris.The anchor was also bent and suture was loose in the box.One undated photo of the device was provided for review and confirms the reported breakage.Per case details, the broken anchor was retrieved from the patient.The procedure was completed using a back-up device.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include unintended excessive force on insertion or off-axial insertion.No containment or corrective actions are recommended at this time.Correction: h6: health effect - clinical code.

• Brand Name: HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 14766530
• MDR Text Key: 294489937
• Report Number: 1219602-2022-00899
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010657862
• UDI-Public: 03596010657862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203378
• Device Catalogue Number: 72203378
• Device Lot Number: 2078997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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 Sex: Female
• Patient Weight: 55 KG