MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON PEEK DS ANCHOR W/ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	210030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 5 of 5 for (b)(4).It was reported by a healthcare professional in china that during an unknown surgery on (b)(6) 2022, it was observed that the suture on the gryphon peek ds anchor w/orthocord device broke upon tightening.Changed to another four same devices to continue the surgery but the same problem happened again.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be 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.Additional narrative: 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.
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, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that suture was frayed and broken; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l57996, and no nonconformances were identified.The photos do not provide enough evidence to determine root cause.Without physical evaluation of the devices reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause for the broken suture can be attributed to procedures variables such as: snaps or other instrument to pull the suture without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it, however, this cannot be conclusively determined.As per ifu, it indicated to apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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: GRYPHON PEEK DS ANCHOR W/ORTHOCORD
• 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: 15642289
• Report Number: 1221934-2022-03209
• Device Sequence Number: 5677616
• Product Code: MAI
• UDI-Device Identifier: 10886705019939
• UDI-Public: 10886705019939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• 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

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: 09/30/2024
• Device Model Number: 210030
• Device Catalogue Number: 210030
• Device Lot Number: 8L57996
• 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: 10/08/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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