MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX3 PEEK ANC.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222207
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter phone number (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that during the surgery of rotator cuff suture , when removed the shaft, noted the anchor was also pulled out.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during the surgery of rotator cuff suture , when removed the shaft, noted the anchor was also pulled out.The complaint device was received and evaluated.Visual observation reveals that the anchor is off the inserter, confirming this complaint.The proximal end of the thread anchor was broken.Also, the cancellous threads on the anchor were stripped.Finally, it was identified some tissue debris.The possible root cause for the anchor pulled out the inserter could be related to the damaged in the anchor as it was broken in the proximal tip where connect into the inserter.For the damage in the anchor can be attribute with off axis, levering or excessive force was used during insertion.However, it cannot be conclusively affirmed.  a manufacturing record evaluation was performed for the finished device lot number:l954339, and no non-conformances 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: 5.5 HEALIX3 PEEK ANC.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10465166
• Report Number: 1221934-2020-02320
• Device Sequence Number: 14054443
• Product Code: MAI
• UDI-Device Identifier: 10886705007554
• UDI-Public: 10886705007554
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

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: 06/30/2021
• Device Model Number: 222207
• Device Catalogue Number: 222207
• Device Lot Number: L954339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/07/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/03/2020; 09/08/2020
• Patient Sequence Number: 1