MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.4MM SHRT NDLS 10PK; PROSTHESIS, SPORTSMED

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 912069; jgrknt 1.4mm shrt ndls 10pk; lot# 810490.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00313.Remains implanted.
Event or Problem Description
It was reported that the suture was pulling out from the needle during anchor implantation.The anchors were successfully implanted when other needle was used.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: JGRKNT 1.4MM SHRT NDLS 10PK
• Common Device Name: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9653361
• Report Number: 0001825034-2020-00312
• Device Sequence Number: 19302107
• Product Code: MBI
• UDI-Device Identifier: 00880304511699
• UDI-Public: (01)00880304511699
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K110145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 912069
• Device Lot Number: 810490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 06/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1