MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR KNOTLESS SUTURE ANCHOR HIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202397
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when scrub nurse began opening the bioraptor knotless anchor, noticed the sterile packaging was impaired, two small holes were noticed in packaging.Unsterile anchor was not opened and other new bioraptor knotless anchor was opened without issue.No case involved.Therefore, there was no patient involved.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, intended for use 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 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 a repeat issue.A review of the packaging found that it must be free of nicks and particulates.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 evaluation will be reopened for investigation.
Additional Manufacturer Narrative
H3,h6: the reported device, intended for use in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned in an unopened pouch.All seals were standard.At the location of the horizontal seal, there were two puncture marks.The puncture through the seal went through the plastic and paper.The puncture within the sterilization package went through the paper only.The puncture occurred from the inside of the packaging outward, likely piercing the seal when it was folded over.A pinpoint puncture was found on the inside flap of the box that corresponded to the puncture in the sterilization pouch.It was determined that this most likely occurred in transit.A review of the device 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 a repeat issue.A review of the packaging found that it must be free of nicks and particulates.The complaint was confirmed and the root cause was associated with transport or storage.Factors that could have contributed to the reported event include rough shipping and handling, an inadvertent impact event, or excessive shaking in transport.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR HIP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11140293
• Report Number: 1219602-2021-00094
• Device Sequence Number: 846890
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093428
• 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): 05/06/2021

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: 10/26/2024
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 2042566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/12/2021; 05/06/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/18/2021; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1