MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS PLUS W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212726
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the inserter of the device was bent.It was communicated that the user was off angle when trying to insert the anchors.When the anchor is inserted off angle and with excessive force it has the potential to cause the device to deform, therefore is a potential root cause for the reported failure.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (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 this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep that the surgeon bent the bioknotless anchors devices trying to fixate them with a patient during rotator cuff repair surgical procedure.According to the reporter, the surgeon seemed to be off angle when trying to engage.There were no patient consequences or delays.The case was completed with other like devices in the same bone holes.The devices are being returned.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.

• Brand Name: BIOKNOTLESS PLUS W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8019297
• Report Number: 1221934-2018-55101
• Device Sequence Number: 19177598
• Product Code: MAI
• UDI-Device Identifier: 10886705002122
• UDI-Public: 10886705002122
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 212726
• Device Lot Number: L421829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1