MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203801
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up, the packaging of the healicoil was badly sealed and therefore open in the box.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).This report was inadvertently submitted under manufacturer report number (b)(4), correct manufacturer report number is (b)(4).
Additional Manufacturer Narrative
B5 was updated.H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned with and outside of original packaging and the device does not have debris on it.The anchor and sutures look good and in place.No physical damage is visible to the device.The tip protector of the device is slightly compressed, and the pouch shows no signs of an incomplete seal.There is residue on the chevron end of the pouch indicating that a seal was present on the device and has been peeled open.A functional evaluation of the returned device found that mechanical portion of the device does work.Device passed all functional tests.There was no way to determine if the device contributed to the reported event.The complaint was confirmed.Factors, which could have contributed to the complaint event, include improper transport or storage.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.A complaint history review found no similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging procedure found that each component should be visually inspected for all non-conforming attributes defined in the procedure.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during set up, the packaging of the healicoil was found to be badly sealed, therefore, it was opened in the box.There was no patient involvement.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12752523
• Report Number: 1643264-2021-02394
• Device Sequence Number: 1388885
• Product Code: MAI
• UDI-Device Identifier: 00885554031430
• UDI-Public: 00885554031430
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 72203801
• Device Catalogue Number: 72203801
• Device Lot Number: 2067937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 03/24/2022; 03/31/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 03/31/2022; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown