MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX TI ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222253
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/09/2019
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.(b)(4).The expiration date is not available.
Event or Problem Description
It was reported by the affiliate via the cst tool that during an unknown procedure the white part of the anchor inserter was detached from the metal part when pulling away after inserting the anchor.The surgeon tried to hammer it away but the white part detached.The inserter was removed with pliers and the procedure was completed with no patient consequences.The affiliate reported a delay of 2 minutes.Additional information provided by the affiliate on 01/20/2019 stating that surgical intervention is not planned and the anchor was able to be inserted into the bone.There is no debris left in the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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: the complaint device was received and inspected.The complaint can be confirmed.The inserter was received still attached to the handle, however pulled out slightly.Small indentations were observed at the distal tip where the anchor sits against the inserter.Per the ifu, slight downward force should be applied to insert the anchor into the bone.If the user applies excessive force to drive the anchor into the bone, this may result in the anchor becoming stuck to the inserter.When the user attempts to release the anchor from the inserter at this point, the insert may become detached from the handle therefore is a potential root cause for the reported failure.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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).The expiration date is not available.

• Brand Name: 4.5 HEALIX TI ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8298140
• Report Number: 1221934-2019-56300
• Device Sequence Number: 2462630
• Product Code: HWC
• UDI-Device Identifier: 10886705007998
• UDI-Public: 10886705007998
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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 Catalogue Number: 222253
• Device Lot Number: L649482
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1