MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5 HEALIX ADVANCE KNTLS PEEK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222585
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/22/2019
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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure the sales rep's two 5.5 healix advance knotless peek anchors distal tips were cheesewired while loading.Both anchors were loaded with one suture of permatape and one suture of orthocord per kite.The case was completed with a third like-anchor by using a slightly different angle.The sales rep stated that only one bone hole was created in the patient.The case was completed without patient harm, but there was a two minute surgical delay to reload the anchors.The anchors are returning for evaluation.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 received and evaluated.Visual observation confirms the anchor cheesewired, confirming this complaint.This cheesewiring effect has been typically observed due to excessive tension being placed on the sutures during anchor deployment which is consistent with the observed failure on this complaint anchor.Therefore it is the root cause for the reported failure.No nonconformances were identified for this part number, lot number combination per qlik query executed on 5/23/2019.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).

• Brand Name: 5.5 HEALIX ADVANCE KNTLS PEEK
• 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: 8717001
• Report Number: 1221934-2019-57377
• Device Sequence Number: 19388262
• Product Code: MBI
• UDI-Device Identifier: 10886705030347
• UDI-Public: 10886705030347
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 05/31/2021
• Device Catalogue Number: 222585
• Device Lot Number: L918916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1