MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIO-ABSORBABLE

Catalog Number	222299
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received.Currently the evaluation is still in progress.However, the preliminary visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture, confirming the complaint.Under magnification, it was observed that some tissue/debris was present on the anchor.The presence of tissue on the anchor and the suture indicated that the anchor was used on the patient.No structural anomalies were observed on the anchor and the inserter.The inserter sleeve looked intact and not damaged.It is a possibility that the anchor was not seated properly during assembly.There is a possibility that the anchor was implanted or implanted and removed.Due to this possibility, this event will be reported since the risk posed to the patient is that based on history of a previous tissue/bone damage harm that was caused by this failure.(b)(4).
Event or Problem Description
It was reported that the anchor detached of the screwdriver.The anchor could not be placed.Use of another anchor.No patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture, confirming this complaint.Under magnification, it was observed that some tissue/debris was present on the anchor.The presence of tissue on the anchor and the suture indicated that the anchor was used on the patient.No structural anomalies were observed on the anchor and the inserter.The inserter sleeve looked intact and not damaged.It is a possibility that the anchor was not seated properly during assembly.However, we cannot discern a definite root cause for this failure at this point in time.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaint of any kind for this lot of devices that were released to distribution.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.Udi: (b)(4).

• Brand Name: 5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIO-ABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7401002
• Report Number: 1221934-2018-50417
• Device Sequence Number: 19267758
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 01/31/2020
• Device Catalogue Number: 222299
• Device Lot Number: L291157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1