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

Model Number	72203984
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case(b)(4).
Event or Problem Description
It was reported that, during a shoulder joint surgery, when the healicoil's package was opened it was found that the sterilization package was not sealed.There was a backup device available and no significant delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with all relevant packaging in place.The seals along the sides of the tyvek pouch and at the chevron end were inspected and appeared to be sealed adequately.The seal along the top of the pouch, however, was missing.There was no residue from the seal being opened either, indicating that this was a problem prior to arrival at the customer site.There was no debris or other indication of use.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 the process summary for packaging found that the tyvek pouch missing a final seal after the product is packaged is classified as a critical defect.The process necessary for creating the final seal was specified appropriately.The complaint was confirmed and the root cause was associated with manufacturing.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with all relevant packaging in place.The seals along the sides of the tyvek pouch and at the chevron end were inspected, and no problem was found.The open top of the pouch was standard.There was no debris or other indication of use.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 the packaging drawing found that the packaging is specified to be sealed on the chevron end and along the sides.No seal is specified at the top of the pouch.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11113368
• Report Number: 1219602-2021-00017
• Device Sequence Number: 19798077
• Product Code: MBI
• UDI-Device Identifier: 00885554032116
• UDI-Public: 00885554032116
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 07/09/2024
• Device Model Number: 72203984
• Device Catalogue Number: 72203984
• Device Lot Number: 50815373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 02/23/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/06/2021; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 70