MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR KNOTLESS SA PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72205021

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  Injury  

Event Description

It was reported that, during a posterior labral repair surgery, when the surgeon was trying to put the "microraptor knotless (sa peek)" in the posterior glenoid (very inferior drill hole).Upon insertion the eyelet came off and the anchor and the screw floated away.The screw, eyelet and all the components were successfully removed from the patient.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a posterior labral repair surgery, when the surgeon was trying to put the "microraptor knotless (sa peek)" in the posterior glenoid (very inferior drill hole).Upon insertion the eyelet came off and the anchor and the screw floated away.The screw, eyelet and all the components were successfully removed from the patient.The procedure was successfully completed without significant delay using a back-up device in the same bone hole.No additional complications were reported.

Manufacturer Narrative

A3: patient sex added b5: event description updated.

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: incomplete anchor insertion may result in the anchor not functioning as intended.Do not attempt to implant this device within cartilage epiphyseal growth plates or non-osseous tissue.As in all suture anchor or suturing techniques, until biological attachment of tissue to bone is complete the fixation should be considered temporary and may not withstand weight bearing or other unsupported stresses.The suture anchor and suture are not intended to provide indefinite biomechanical integrity.¿ ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair a relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: MICRORAPTOR KNOTLESS SA PEEK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10730650
• MDR Text Key: 212966146
• Report Number: 1219602-2020-01650
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 00885556722527
• Combination Product (y/n): N
• PMA/PMN Number: K181746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

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 Expiration Date: 09/12/2022
• Device Catalogue Number: 72205021
• Device Lot Number: 50827857
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 01/06/2021
• Supplement Dates FDA Received: 11/04/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention