MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203983

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/07/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair, the healicoil inserter broke while screwing it into the shoulder, all pieces were removed using graspers; the procedure was completed without delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.An analysis of the customer provided image shows a broken anchor on broken device.A visual inspection revealed the device was not returned with original packaging.The anchor does have debris on it.Anchor is still on tip of shaft.The anchor tip is separated from main shaft of device.Further review of twist off found galling on both faces.No other physical damage is visible to the device.A functional evaluation of the returned device found that mechanical portion of the device does work.Device passed all functional tests.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 found there are requirements for conformance and a certificate of material analysis is required based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.Although it was reported the anchor and part of inserter was left behind in the shoulder, per communications, the surgeon removed them with a grasper without a delay using a back-up device.Since no other complications were reported, no further clinical/medical, assessment is warranted at this time.It was determined the device did not contribute to the reported event the complaint was confirmed and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.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.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP 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: 10784617
• MDR Text Key: 214534849
• Report Number: 1219602-2020-01760
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: 00885554032109
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 05/20/2022

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 Expiration Date: 07/19/2023
• Device Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: 2017767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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