MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during surgery for the right leg on (b)(6) 2019, a healix ti anchor broke.The device broke at the moment of starting the insertion and it broke into a point anchor screwdriver.The fragments were removed and a back up used to complete the surgery.A 10 minute surgical delay was noted.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [2l82128] number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Device history the batch review 2l82128 showed that the 300 devices were conformed to in process and finished goods specifications when released to stock on (b)(6) 2019.Expiration date: december 31st 2021 (according to retained labels).No nc was opened.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9285477
• Report Number: 1221934-2019-59442
• Device Sequence Number: 13984804
• Product Code: MBI
• UDI-Device Identifier: 10886705007882
• UDI-Public: (01)10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 12/31/2021
• Device Model Number: 222242
• Device Catalogue Number: 222242
• Device Lot Number: 2L82128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/08/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1