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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 4 of 4 for (b)(4).It was reported by a healthcare professional in china that during a meniscal repair procedure on an unknown date, it was observed that two plates on the truespan meniscal repair system peek 12 degree device were deployed at the same time after the first firing.Changed to another truespan meniscal repair system peek 12 degree device to continue the surgery but the same problem happened again.Changed to truespan meniscal repair system peek 24 degree device to continue the surgery but its suture broke off when tightened the suture.And then use fastin rc 5mm orthocord w/o needles device but its suture also broke off.Another like device was used to complete the surgery.There were no adverse consequences to the patient 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 lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.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 4 of 4 for (b)(4).It was reported by a healthcare professional in china that during a meniscal repair procedure on (b)(6) 2023, it was observed that two plates on the truespan meniscal repair system peek 12 degree device were deployed at the same time after the first firing.Changed to another truespan meniscal repair system peek 12 degree device to continue the surgery but the same problem happened again.Changed to truespan meniscal repair system peek 24 degree device to continue the surgery but its suture broke off when tightened the suture.And then use fastin rc 5mm orthocord w/o needles device but its suture also broke off.Another like device was used to complete the surgery.There were no adverse consequences to the patient 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 the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16726348
• Report Number: 1221934-2023-01597
• Device Sequence Number: 7209577
• Product Code: MBI
• UDI-Device Identifier: 10886705008711
• UDI-Public: 10886705008711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Model Number: 222993
• Device Catalogue Number: 222993
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 04/13/2023; 06/08/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/12/2023; 04/13/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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