MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX BR ANCHOR W/OCORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.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.Upon visual inspection of the photo, it was observed that the anchor is broken into two pieces, the broken pieces are still attached to the inserter.The overall complaint was confirmed as the observed condition of the 4.5 healix br anchor w/ocord would contribute to the complained device issue.A review of the batch manufacturing records was conducted on finished lot number 226l800; and no related non-conformances were identified.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment occurred and consequently cause the anchor breakage.As per ifu: improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.It has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported from china that during a rotator cuff repair procedure, it was observed that the anchor on the 4.5 healix br anchor w/ocord device broke off.Another like device was used to complete the procedure.There were no adverse consequences to the patient reported nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided, it was reported that during the surgery, the anchor was broken off (as the photo shows).A photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Upon visual inspection of the photo, it was observed that the anchor is broken into two pieces, the broken pieces are still attached to the inserter.The overall complaint was confirmed as the observed condition of the 4.5 healix br anchor w/ocord would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment occurred and consequently cause the anchor breakage.As per ifu 109362; improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.It has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Document specification review: ifu-109362.Device history lot: pn: 222229.Lot number: 226l800.There was no non conformance regarding this lot.Manufacturing date: 14 sep 2023.Expiry date: 31 aug 2026.Quantity: (b)(4).Release date: 06 oct 2023.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.Device was used for treatment, not diagnosis.H6: the investigation findings and conclusions have been updated to reflect the correct information.,.
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.Device was used for treatment, not diagnosis.Investigation summary : the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the device received.Visual inspection reveled that the anchor is broken into two pieces, the broken pieces were still attached to the inserter.The rest of the device does not show structural anomalies.Slight residues of foreign matter, presumably biological were found in the distal part of the anchor.The overall complaint was confirmed as the observed condition of the 4.5 healix br anchor w/ocord would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment occurred and consequently cause the anchor breakage.As per ifu; improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.It has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a review of the batch manufacturing records was conducted on finished lot number 226l800: and no related non-conformances were identified.
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.Device was used for treatment, not diagnosis.H4: the device manufacture date has been updated accordingly.

• Brand Name: 4.5 HEALIX BR ANCHOR W/OCORD
• Common Device Name: 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; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19184883
• Report Number: 1221934-2024-01370
• Device Sequence Number: 7431677
• Product Code: MAI
• UDI-Device Identifier: 10886705007769
• UDI-Public: 10886705007769
• 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: 08/31/2026
• Device Catalogue Number: 222229
• Device Lot Number: 226L800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 05/15/2024; 05/17/2024; 05/22/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/15/2024; 05/15/2024; 05/17/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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