MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222299
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by the sales representative via phone that two 5.5 healix advance br w/oc&nd anchors broke when inserted.It was reported the third device worked perfectly.No harm to patient.No significant delay in surgery time.Additional information provided by the sales representative reported only 1 device will be returned for evaluation because the other device was discarded.
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, the anchor was broken off.The complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor was broken and was found detached form the shaft, but is held in place by suture.In addition, the device presented evidence of biological residues in the anchor, handle and in the sutures.When observed under magnification, no structural anomalies were observed.The complaint can be confirmed.The possible root cause for the reported failure can be associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [6l77852] number, 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 HEALIX ADVANCE BR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10359118
• Report Number: 1221934-2020-01988
• Device Sequence Number: 3462611
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 02/28/2023
• Device Model Number: 222299
• Device Catalogue Number: 222299
• Device Lot Number: 6L77852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1