MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 2.9MM #2 BLUE MB SNGL NGLE; SPORTSMED, IMPLANTS

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	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in (b)(6).Visual examination of the returned product identified that the anchor was visually conforming to print.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery, the anchor got pulled out from burr hole when the surgeon pulled the suture after it was implanted.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This report was submitted in error.All information pertaining to this complaint was filed under the resubmission of the initial report.Initial report: 0001825034-2019-04180.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: JGRKNT 2.9MM #2 BLUE MB SNGL NGLE
• Common Device Name: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9652700
• Report Number: 0001825034-2019-04180
• Device Sequence Number: 1877287
• Product Code: MBI
• UDI-Device Identifier: 00880304522350
• UDI-Public: (01)00880304522350
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 11/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 912029
• Device Lot Number: P11308
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/04/2020
• 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: NI
• Patient Sequence Number: 1