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

Model Number	212726
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (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.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an unknown procedure that the threaded portion of the inserted remained in the bioknotless plus w/ orthocord after insertion.There's no additional information at the time of the call.No patient consequences reported.Additional information provided by the affiliate reported the event occurred during a shoulder arthroscopy and the case was completed deciding the keep the anchor in the glenoid of the patient with the tip of the inserted still inside.It was reported the surgeon did not attempt to remove the inserter from the patient and there are no known adverse effects to patient.
Additional Manufacturer Narrative
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.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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.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.H10 additional narrative: additional information: d4: the expiration date was reported as unknown on the initial report and has been updated as 4/30/2022.: investigation summary:the device was received and inspected.Upon visual inspection, it was noticed that the distal tip was found to be broken off and the broken piece was not received.Hence the complaint can be confirmed for the broken tip.However, the complaint condition for the embedded device cannot be confirmed since the xray/image was not provided.Further observation reveals that the device was found to be bent at the distal portion.We cannot determine a definitive root cause.A possible root causes could be excessive force may have been applied during use.No structural anomalies were observed.A manufacturing record evaluation was performed for the finished device lot number (4l24157), and no non-conformances related to the reported complaint condition were identified.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.Device history review: a manufacturing record evaluation was performed for the finished device lot number (4l24157), and no non-conformances related to the reported complaint condition were identified.

• 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: 9683924
• Report Number: 1221934-2020-00512
• Device Sequence Number: 502443
• Product Code: MAI
• UDI-Device Identifier: 10886705002122
• UDI-Public: 10886705002122
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 212726
• Device Catalogue Number: 212726
• Device Lot Number: 4L24517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/05/2020; 03/23/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/05/2020; 03/24/2020
• Patient Sequence Number: 1