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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK ST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
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.
 
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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 Key12502334
MDR Text Key272430378
Report Number1219602-2021-02081
Device Sequence Number1
Product Code MBI
UDI-Device Identifier00885556767351
UDI-Public885556767351
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K193558
Number of Events Reported1
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 Number72205138
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2021
Initial Date FDA Received09/20/2021
Supplement Dates Manufacturer Received09/17/2021
03/29/2022
Supplement Dates FDA Received10/08/2021
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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