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

Catalog Number 72205135

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

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that on pmcf review map 946 healicoil anchor, 1 patient reported 6 weeks after the shoulder procedure where a healicoil anchor was used, that it was experiencing a fair amount of pain, which affected their sleep.Stiffness was also a major concern.At the time of the visit forward flexion was only up to 60 degrees, and external rotation was ¿barely to neutral.¿ at the time of this visit, they were diagnosed with adhesive capsulitis.A more aggressive physical therapy was started as well as a course of decadron and oxycodone.2 months following surgery, patient reported improvement in pain, but was still quite stiff.At the time of this visit, the external rotation was only to about 20 degrees.No changes were made to the care at that time.4 months after the surgery, it had made significant improvement in regards to pain, but range of motion was still quite limited.External rotation at the time of visit was still only to about 10 degrees and internal rotation was only to about their waist.7 months after their surgery, patient had completely stopped any medication for pain.Their range of motion had also considerably improved.They could get forward flexion to almost 150, some tightness was still experienced in internal and external rotation.At that point, it was decided that the patient had recovered adequately to only return to the clinic at an as needed basis.No further information is available.

Manufacturer Narrative

H10: additional information: d1, d2, d4, e1 and g4 (pma/510(k)number) updated.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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 RGNST
• 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: 15939826
• MDR Text Key: 305060693
• Report Number: 1219602-2022-01936
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767146
• UDI-Public: 885556767146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72205135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2023
• 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): Other; Required Intervention