MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE PEEK 3SUT W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer 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.
Event or Problem Description
It was reported by the sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the hex head of the inserter on the 6.5 healix advance peek 3 suture anchor w/ orthocord device broke off in the patient.According to the report, the fragment could not be found and it was not retrieved.It was further reported that x-rays confirmed the presence of the cannulated portion of the device in the patient´s body.The status of the patient post-surgery was unknown.No additional information was provided.
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.H6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 = according to the information provided, it was reported that when the inserter was removed from the lesion, the tip came off.The fragment was removed from the patient¿s body.The complaint device was received and evaluated.Upon visual inspection, it could be observed that, the tip of the inserter shaft is detached from the shaft.On magnification, it is observed that the welding points are broken due to the manipulation, friction marks were found inside the shaft.A manufacturing record evaluation was performed for the finished device lot number: 6l47233, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.A root cause for the detached inserter tip can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment or bending force was applied to the inserter.As per ifu: 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: b5: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that the broken tip/hex tip was embedded in the cannulated portion of the anchor and was not floating in the joint.It was reported that there is currently no plan to surgically remove it.It was reported that the patient has not been affected by the metal piece.

• Brand Name: 6.5 HEALIX ADVANCE PEEK 3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12675300
• Report Number: 1221934-2021-03105
• Device Sequence Number: 4233037
• Product Code: HWC
• UDI-Device Identifier: 10886705021451
• UDI-Public: 10886705021451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 222311
• Device Catalogue Number: 222311
• Device Lot Number: 6L47233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/24/2021; 10/27/2021; 12/06/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 10/26/2021; 10/28/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown