MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, instruments inside patient, the healicoil anchor broke.The procedure was completed with a s+n back up device.No significant delay and no patient injury or other complications were reported.
Event or Problem Description
It was reported that during a shoulder arthroscopy, instruments inside patient, the healicoil anchor broke.Th broken pieces were removed using tweezers.The procedure was completed with a s+n back up device, no additional bone hole was necessary.No significant delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference:(b)(4).H2: additional information ¿b5¿ h3, h6: 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 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.A review of the packaging process summary found that the storage requirements, material specifications, and material tests were appropriately documented a review of risk management files found that the reported failure was documented appropriately.Per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.According to the report, the broken pieces of the healicoil anchor were removed from inside of the patient with tweezers.Based on the information provided, the procedure was completed with a s+n back up device using the same bone hole without a significant delay.Since there was no patient injury or other complications reported; no further clinical/medical assessment is warranted at this time.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.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 RG SA 5.5MM W/2 UB-BL CBRD BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12509458
• Report Number: 1219602-2021-02093
• Device Sequence Number: 5159414
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: 72203706
• Device Catalogue Number: 72203706
• Device Lot Number: 2062971
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other