MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HEALIX AV BR 4.5 TAPE WHT/BLUE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed 03/29/2019.No further information regarding the technique or instruments 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 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).
Event or Problem Description
It was reported by the sales rep via cst that during an unknown procedure the 4.5 healix advance anchor with permacord suture, white/blue, broke when inserting into the bone.It is unknown if fragments were generated.The case was completed with a new anchor with no issues.There was no patient harm or surgical delay.The device was discarded by the customer.

• Brand Name: HEALIX AV BR 4.5 TAPE WHT/BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8510445
• Report Number: 1221934-2019-56837
• Device Sequence Number: 941901
• Product Code: MAI
• UDI-Device Identifier: 10886705027804
• UDI-Public: 10886705027804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 01/31/2021
• Device Catalogue Number: 222360
• Device Lot Number: L758230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1