MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HEALIX AV BR 5.5 TAPE BLUE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure, the customer's 5.5 healix advance anchor with blue permatape suture broke upon insertion.The anchor was broken midway down.The anchor was removed from the patient with no fragments left behind.The sales rep stated the patient had normal bone density.The case was completed using another like-device in the same bone hole with no patient harm or delays.The device is being returned for evaluation.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the complaint device was received and evaluated.Only the broken anchor and the sutures were returned for evaluation.Visual observation revealed a break in the anchor middle body, confirming the complaint.The inserter shaft was not returned with the implant device.Both sutures were returned, no anomalies found.The suture bridge was intact.As reported the anchor broke upon inserting the anchor into the prepared bone hole.Visible surgical debris is shown on the broken anchor, middle section.Possible root cause for the user to experience this type of failure could be off axis insertion, excessive levering during insertion, using incorrect instrumentation for preparing bone hole.This failure could be attributed to user technique.However, a specific root cause could not be determined.A non-conformance search was performed for this part#: 222361 lot#: l570380 combination and no nonconformances were identified.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 to monitor the extent to which this complaint is observed in the field.

• Brand Name: HEALIX AV BR 5.5 TAPE BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7934593
• Report Number: 1221934-2018-54802
• Device Sequence Number: 10955086
• Product Code: MAI
• UDI-Device Identifier: 10886705027811
• UDI-Public: 10886705027811
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 10/31/2020
• Device Catalogue Number: 222361
• Device Lot Number: L570380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1