MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT SHORT RIGID SZ1 IMP/DRL; SPORTSMED, IMPLANTS

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 904759; lot# 068640; ziptight ankle syn fixation-ti ion ti.Foreign: event occurred in (b)(6).The product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2020-04449.
Event or Problem Description
It was reported that during inspection, the piece was found open.Not patient involved.No surgery occurred.
Additional Manufacturer Narrative
Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.

• Brand Name: JGRKNT SHORT RIGID SZ1 IMP/DRL
• Common Device Name: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11154613
• Report Number: 0001825034-2020-04448
• Device Sequence Number: 2590782
• Product Code: MBI
• UDI-Device Identifier: 00880304568198
• UDI-Public: (01)00880304568198
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 110005307
• Device Lot Number: 575900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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