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

Model Number 210813

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

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).Investigation summary both photo of the complaint device and the actual device were received for evaluation.Upon visual inspection of the photo, the device anchor is shown broken on the proximal end.Upon visual inspection of the device, the device anchor was found broken on the proximal end.A manufacturing investigation was performed 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 per tm-tme0091 rev48, wi-ft0018rev26, pic-vs121rev4, pic-vse0028 rev8, pic-vse0030 rev21.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.According with suture insertion procedure (sws-0525 rev4 and sws-0555 rev.4) it is not possible to insert the sutures with a broken anchor.It has been verified that all personnel is trained and certified in procedures.According to process failure modes and effects analysis pfmea- 103161292rev2: the potential occurrence of having a broken anchor has been evaluated to (b)(4) since 2016.Effect of having a broken anchor has been evaluated in the wi-6474 rev23 by combining probability and severity levels.0 complaints received over 162959 parts produced since 2016.(b)(4).The root cause is not manufacturing related.A manufacturing record evaluation was performed for the finished device 8l77969 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.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.

Event Description

Packing anchor breakage.It was reported by a healthcare professional in china that during an arthroscopic repair of glenoid lip procedure on (b)(6) 2022, it was observed that the anchor on the gryphon p br ds anchor w/orthocord was broken upon opening its package.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.

• Brand Name: GRYPHON P BR DS ANCHOR W/ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, 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: 15447701
• MDR Text Key: 300463258
• Report Number: 1221934-2022-02847
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001279
• UDI-Public: 10886705001279
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 210813
• Device Catalogue Number: 210813
• Device Lot Number: 8L77969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female