MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PEEK WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual inspection of the device revealed one of the threader wire loops on the threader tab was broken, confirming this complaint.Visual inspection of the returned versalok anchor and inserter revealed no anomalies.It was reported that the wire broke on the suture; a potential root cause for the device failure is more than two strands being threaded through the wire loop, which can become jammed in the eyelet of the anchor resulting in the wire break.Other than this possibility, a definitive root cause for this device failure cannot be determined.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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.(b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep via phone call that their versalok peek with orthocord failed at a rotator cuff repair for their customer.The wire broke on the suture prior to using it on the patient once removed from packaging.The procedure was completed using another device.There was no adverse patient consequence nor time delays reported.The device will be returned for evaluation.

• Brand Name: VERSALOK PEEK WITH ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7775618
• Report Number: 1221934-2018-53076
• Device Sequence Number: 1319939
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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
• Report Date (Section B): 12/13/2016

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: 05/31/2018
• Device Catalogue Number: 210818
• Device Lot Number: 3850491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 08/11/2018
• Patient Sequence Number: 1