MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5MM ORTHOCORD W/O NEEDLES; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222993
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
This is report 3 of 5 for (b)(4).It was reported by a healthcare professional that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that there was a pinhole in the foil wrapping of the fastin rc 5mm orthocord w/o needles device.According to the report, the issue was noticed upon opening the package of the device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the foil pouch is open and is damaged, it has small perforation.A partial part of the desiccating paper sheath is shown.A manufacturing record evaluation was performed for the finished device 7l66423 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection, this complaint can be confirmed.The manufacturer performed an investigation with the following results: an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also pert (b)(4) rev25, (b)(4) rev45.The result of this process check is successful, none of the 9 parts were non-conformed.So, there is no need to inspect more parts of the batch nor raise a non-conformance.The batchs have been assembled by operators trained and certified on the process validated in production.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Effect of having one of a perforation on the foil pouch upon code 222993 has been evaluated in the (b)(4) rev y by combining probability and severity levels.0 complaints received over 121393 parts produced since 2016.(b)(4).This risk is acceptable.The analysis showed that the production controls implemented guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that found a perforation on the foil pouch does not occur in the manufacturing process.We can conclude that it is highly unlikely that these defects were generated during the manufacturing process.Therefore it could be related to procedural variables, such handling of the device or product interaction before procedure, a mishandling of the device while it was being unpackaged can lead to damages in the foil pouch, however this cannot be conclusively determined, at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: FASTIN RC 5MM ORTHOCORD W/O NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17081149
• Report Number: 1221934-2023-02334
• Device Sequence Number: 2250423
• Product Code: MBI
• UDI-Device Identifier: 10886705008711
• UDI-Public: 10886705008711
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 12/31/2023
• Device Model Number: 222993
• Device Catalogue Number: 222993
• Device Lot Number: 7L66423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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