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

Catalog Number	222242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Tissue Damage (2104)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.
Event or Problem Description
Event: necrosis of the edges through the wound and sorosanguineous secretion 3 days after the intervention.It was performed immediate cleaning and every three days continuously.A radiographic image shows the presence of a black halo.The surgeon indicates that he wish to perform removal of the titanium healix anchor and requested material for removal of the implant and orthocord suture for ligament repair that will be necessary after removing the anchor.Patient requires next intervention as soon as possible.The procedure was prolonged in 90 minutes.
Additional Manufacturer Narrative
The expiration date was documented as unknown in the initial report and has been updated as 2/29/2020.Therefore, udi: (b)(4).Device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate 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 complaints of any kind for this lot of devices with the product code that were released to distribution.No further information regarding the technique used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective and preventative 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 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: 7593540
• Report Number: 1221934-2018-51692
• Device Sequence Number: 13906631
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: 10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 222242
• Device Lot Number: L336183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Weight: 85