MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5HLX ADV BR ANC-DYNA 3-SUT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
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.Investigation summary: the complaint device was implanted therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.(b)(4).The expiration date and lot number are not available.
Event or Problem Description
It was reported by the sales rep via email that in relation to an unknown revision procedure there was an issue with the 5.5mm healix advance anchor with dynacord suture.The sales rep stated that the patient fell after the initial surgery.The sales rep could not provide the date of the original procedure, the date of the revision procedure, or the type of procedure.The sales rep also could not provide how the anchor malfunctioned or the lot number for the anchor.Additional information provided by sales representative on 12/27/2018 reporting that a revision surgery was performed with same anchor, but with orthocord suture and a new bone hole was used for the new anchor.

• Brand Name: 5.5HLX ADV BR ANC-DYNA 3-SUT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8204079
• Report Number: 1221934-2018-55866
• Device Sequence Number: 1670409
• Product Code: MAI
• UDI-Device Identifier: 10886705029457
• UDI-Public: 10886705029457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/28/2018
• Patient Sequence Number: 1