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

Catalog Number 72205138

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Foreign Body In Patient (2687)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that a rotator cuff reconstruction was preformed on april, during the surgery it was used a healicoil kl pk, 5.0mm sa, self-taping.An x-ray was preformed and it showed that an anchor was dislocated, therefore a revision surgery was necessary and it was preformed on june.The joint was opened and the anchor which was located in the lower recess according to the x-ray image, could not be recovered, so it does not sit firmly in the bone as desired.A delay greater than 3 hours was reported.A backup device was reported as available.Patient shoulder's range of motion is restricted, lifting is possible up to a maximum of 90 degrees, therefore the patient is still in pain.

Event Description

It was reported that a rotator cuff reconstruction was performed, using healicoil kl pk, 5.0mm sa.A revision surgery was needed to remove the anchor that was dislocated in the subacromial space.An opened procedure was required to remove the anchor.A backup device was not required.Patient shoulder's range of motion is restricted, lifting is possible up to a maximum of 90 degrees, therefore the patient is still in pain.

Manufacturer Narrative

B5 was updated.

Manufacturer Narrative

The reported device 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 found no similar reported events.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.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 review of risk management files found that the reported failure was documented appropriately.A review of the material specifications found there are requirements for conformance and a certificate of material analysis is required.This case reports that two months following implantation a revision surgery was performed due to a dislocated anchor.Per the provided implantation report the patient had an arthroscopic supraspinatus tendon suture with two healicoii anchors.The document also notes that the ventrolateral acromion corner had protruding exophytes which represent the mechanical partial cause of the rm tear.The rotator cuff had a reported 8mm long tear.The report also notes an extensive synovectomy at the ventral capsule was performed.It was reported that x-rays within the 2-month period postop showed a dislocated anchor in the subacromial space deep ventrally as an avulsion with dislocation, however, these x-rays were not provided for review.The revision operative report noted ¿the lack of healing of the rotator cuff.¿ the first anchor was retrieved however, due to the malposition of the second anchor a ventral arthrotomy with an open approach was done, and two additional incisions were needed before the second anchor was retrieved.It was noted that ¿a reconstructive attempt can no longer be considered at this time and the operation is terminated.¿ one undated photo of one broken anchor was provided for review.Conclusion: based on the limited information provided the clinical root cause of the reported events could not be determined.It was reported that the patient experiences pain and has restricted range of motion.The root cause of the migration of the anchors cannot be concluded as patient factors and tissue quality are unknown.It¿s stated that due to the extensive procedure to remove one of the anchors that a reconstruction of the rotator cuff was not attempted at that time.It is unknown if there is a future plan for this reconstruction.This event is considered ongoing.No further clinical assessment is warranted at this time.Should additional information become available this issue can be re-elevated.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: HEALICOIL KNOTLESS PK ST
• 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: 12502334
• MDR Text Key: 272430378
• Report Number: 1219602-2021-02081
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

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: 72205138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/17/2021; 03/29/2022
• Supplement Dates FDA Received: 10/08/2021; 04/01/2022
• 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): Required Intervention
• Patient Sex: Male