MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON T BR DS ANCH W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(6) that during an arthroscopic hip repair of glenoid lip procedure on (b)(6) 2022, it was observed that the anchor on the gryphon t br ds anch w/oc device broke.All the broken parts were removed.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
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 mitek or its employees that the report constitutes an admission that the device, 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 has not been returned, therefore unavailable for a physical evaluation.However, photo was provided.Upon visual inspection of the photo, it was observed only the device without the handle cover and the suture was not in place.Finally, it was not possible to see the condition of the anchor.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the visual inspection of the photo, this complaint cannot be confirmed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause of anchor breakage can be associated with off axis insertion and levering during insertion.Moreover, excessive force on the inserter could have resulted damage the anchor.However, it cannot be conclusively affirmed.As per ifu, insert the healix peek anchor into the hole created by the awl while maintaining the same axial alignment and rotate the healix peek inserter handle in a clockwise direction until the etched depth marking on the handle shaft is flush with the bone.Inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Also, it is important to do not apply a bending force to the inserter, this can damage the anchor or inserter tip.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: investigation summary : the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the anchor was cracked but not broken off and was still in the suture.No anomalies found in the suture.A manufacturing record evaluation was performed for the finished device lot number: 5l80159 and no nonconformances were identified.Based on the visual inspection, this complaint cannot be confirmed.The possible root cause for the damage in the anchor can be associated with off axis insertion and levering during insertion.Moreover, excessive force on the inserter could have resulted damage the anchor.However, it cannot be conclusively affirmed.As per ifu, insert the healix peek anchor into the hole created by the awl while maintaining the same axial alignment and rotate the healix peek inserter handle in a clockwise direction until the etched depth marking on the handle shaft is flush with the bone.Inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Also, it is important to do not apply a bending force to the inserter, this can damage the anchor or inserter tip.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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 mitek or its employees that the report constitutes an admission that the device, 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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: GRYPHON T BR DS ANCH W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle, MA CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13623861
• Report Number: 1221934-2022-00643
• Device Sequence Number: 20133569
• Product Code: MAI
• UDI-Device Identifier: 10886705001255
• UDI-Public: 10886705001255
• 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,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 Expiration Date: 07/31/2022
• Device Model Number: 210811
• Device Catalogue Number: 210811
• Device Lot Number: 5L80159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 03/14/2022; 03/29/2022; 04/01/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/04/2022; 03/15/2022; 03/30/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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