MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON P BR DS ANCHOR W/OC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 210813

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/24/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep in china that during an unspecified surgical procedure on (b)(6) 2023 the gryphon p br ds anchor w/oc device packing anchor was deformed and broken.During in-house engineering evaluation, it was determined that the device anchor and suture were detached from the tip.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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.Udi: (b)(4) unknown.Investigation summary: 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 one device without identification, the anchor and suture were detached from the tip.It was not possible to see the condition of the anchor.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, the reported complaint was not confirmed.The device is required for testing, the photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the required evidence to provide a root cause.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.A manufacturing record evaluation was performed for the finished device lot number and no non conformances were identified.

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 product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed that the anchor, suture cover were not returned for evaluation.The suture received was detached from the tip and no anomalies could be identified.Finally, biological matter was found near the tip.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Based on the devices received, this complaint cannot be confirmed, and a root cause cannot be determined.The storage conditions of these devices are unknown, and it is possible that they were exposed to high temperatures probably during transportation/ storage/ trunk stock resulting in the anchors to bend.This product should be stored in a cool dry place, away from moisture and direct heat per ifu.There was no information provided regarding this condition.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.

• Brand Name: GRYPHON P BR DS ANCHOR W/OC
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17959821
• MDR Text Key: 325975601
• Report Number: 1221934-2023-03789
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210813
• Device Lot Number: 166L283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1