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 Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare professional in brazil that during an unknown procedure on (b)(6) 2023, it was observed that the fastin rc 5mm orthocord w/o needles device was not released from the applicator.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.Udi: (b)(4).The device manufacture date is currently unavailable.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.
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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.Visual observations revealed the anchor was slightly deformed near the tip.The suture card was not in place.Biological residues were found near the channel of sutures and distal part.A manufacturing record evaluation was performed for the finished device lot number: 9l33377, and no nonconformances were identified.According with the visual inspection, this complaint can be confirmed.Due to foreign matter condition, a ft-ir (fourier transform infrared spectroscopy) analysis was performed.The purpose of this analysis is to identify chemical composition.Overall, based in the obtained results it can be concluded that foreign material is primarily composed of a biological-base material with what it seems to be high phosphate traces according to the observed peaks.The possible root cause can be related to procedural variables, such handling of the device or product interaction during procedure.As per ifu- 108687, the anchor is screwed directly into the bone without pre-drilling.Twist the fastin rc inserter clockwise until anchor is below the surface of the bone.Incomplete insertion or poor bone quality may result in an chor pullout.Decortication with a rasp, burr, or drill bit prior to manual insertion is recommended.Minimum anchor spacing is 5mm.Bone stock must be adequate to allow proper placement.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• 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: 16657231
• Report Number: 1221934-2023-01418
• Device Sequence Number: 19236053
• Product Code: HWC
• UDI-Device Identifier: 10886705008711
• UDI-Public: 10886705008711
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 06/30/2025
• Device Model Number: 222993
• Device Catalogue Number: 222993
• Device Lot Number: 9L33377
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 06/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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