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

Model Number 210813

Device Problems Crack (1135); Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported by a healthcare professional in china that during a shoulder repair procedure on (b)(6) 2023, it was observed that the anchor on the gryphon p br ds anchor w/orthocord device was cracked and bent upon opening its package.During in-house engineering evaluation, it was determined that the anchor was found cracked in half with its shaft slightly bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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.H10 additional narrative: udi: (b)(4) incomplete.D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.Investigation summary both photo and the complaint device were received and evaluated.A photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the anchor was found cracked in half and the shaft was slightly bent.The complaint device was received and evaluated.Upon visual inspection, the device anchor was found cracked in half.The shaft was slightly bent.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 pert tm-tme0091 rev aw.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, see the proof below.The batches have been assembled by operators trained and certified on the process validated in production, see list below.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes, see proof of training below.Risk assessment: effect of having a cracked anchor for product code 210813 has been evaluated in the wi-6474 rev y by combining probability and severity levels.1 complaint with this problem received over 193095 parts produced since 2016.With a ratio of 0.0005 % < 0.02% and is ranking 1 (= improbable and negligible).This risk is acceptable.During the research between 2016-2023 with the item reference (b)(4), no complaints with the same issue and no related nrs were found.The analysis showed that the production controls implemented at the non-sterile level, as well as the in-process controls guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control of anchor, guarantee that this type of defect does not occur in the manufacturing process.According to wi-emqd122 "process instruction - wi-emqd122, requirements for analysis of automated vacuum drying", no temperature problems because no alarms.The anchor could not be damaged during the drying process.We can conclude that it is highly unlikely that these defects were generated during the manufacturing process.The bounding is limited to this part because the analysis of the complaint shows that there is no other case of defect for these lots.A manufacturing investigation activity was conducted to determine if there were any internal processing issues that may have contributed to the nature of the product complaint.A thorough review of production process controls was conducted.The results show that this batch of product was processed without incident.Nevertheless, there is no evidence of manufacturing anomalies.Based on the above, it is confirmed that the manufacturing process was performed in accordance with the validated processes.The root cause is not related to manufacturing.A possible root cause can be attributed to storage and handling, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 105l136 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.

• 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: 17248630
• MDR Text Key: 318677783
• Report Number: 1221934-2023-02596
• 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: 105L136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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