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

Catalog Number	222361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4).The expiration date is not currently available.
Event or Problem Description
It was reported by the sales rep that their healix advance br 5.5 tape blue anchor broke at the tip upon insertion during a rotator cuff repair.The broke parts were removed with a grasper and another like device was put in the same bone hole to complete the case.There were no patient consequences or delays.The device is being returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and inspected.Visual observation confirms the distal tip of the anchor is broken, but is held in place by suture.This complaint can be confirmed.A definite root cause cannot be determined.However, it is a possibility that anchor breakages are associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.A 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 an nr was generated regarding a documentation issue.Also, a restricted phase was generated regarding a packaging issue.However, both non-conformance's are not relevant to the complaint condition.A review into the depuy synthes mitek complaints system revealed no similar complaint of any kind for this lot of devices that were released to distribution.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 that their healix advance br 5.5 tape blue anchor broke at the tip upon insertion during a rotator cuff repair.The broke parts were removed with a grasper and another like device was put in the same bone hole to complete the case.There were no patient consequences or delays.The device is being returned.

• Brand Name: HEALIX AV BR 5.5 TAPE BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7476889
• Report Number: 1221934-2018-50551
• Device Sequence Number: 1124901
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: L570385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1