MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222301
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2019, it was observed that the anchor on the 6.5 healix advance br3sut w/oc device just idly turned and could not be inserted further when the surgeon tapped an awl during the anchor¿s insertion.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.The device was brand new and its first use when the issue occurred.
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.
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 was an unknown procedure, the surgeon tapped an awl during the anchor¿s insertion.However, the anchor¿s shaft just idly turned and was not able to be inserted further.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number: l991829, and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 6.5 HEALIX ADVANCE BR3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12846873
• Report Number: 1221934-2021-03379
• Device Sequence Number: 19970135
• Product Code: MAI
• UDI-Device Identifier: 10886705021376
• UDI-Public: 10886705021376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2019

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: 08/31/2021
• Device Model Number: 222301
• Device Catalogue Number: 222301
• Device Lot Number: L991829
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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