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

Model Number	222366
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional narrative: investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.One possible root cause of the reported problem could be off axis insertion.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number ( (b)(4)), and no non-conformances related to the reported complaint condition 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 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 sales rep via complaint submission tool that during a rotator cuff repair, while inserting a 5.5mm healix advance¿ peek anchor with permatape¿ suture, white/blue, there was a lot of blood and may have been off access and the anchor tip got bent on not usable.Bone as also hard but correct awl was used to make hole.They used a similar product to complete surgery successfully and no debris was left in patient.No surgical delay or patient consequence reported.

• Brand Name: HEALIX AV PK 5.5 TAPE WHT/BLUE
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10184366
• Report Number: 1221934-2020-01603
• Device Sequence Number: 3233999
• Product Code: MBI
• UDI-Device Identifier: 10886705028009
• UDI-Public: 10886705028009
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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: 04/30/2022
• Device Model Number: 222366
• Device Catalogue Number: 222366
• Device Lot Number: 4L53324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1