MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 1.4MM SHRT W/NDLS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	912068
Medical Device Problem Codes	Fracture (1260); Expulsion (2933); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# 912068; lot# 2504994 e1: full establishment name - (b)(6).G2: foreign - event occurred in (b)(6).Customer has indicated that 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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a procedure, the anchor did not successfully implant into the bone.The surgical technique was followed, and the bone was drilled 1.4mm, but when the anchor was inserted, it did not remain and pulled out.It was also later noticed that the feeder is bent, and two protruding sutures are broken.Another device was used to complete the procedure.No patient consequences were reported as result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the two prongs of the device had broken off.The anchor in the photo exhibits bio-debris consistent with being implanted.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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
No further event information available at the time of this report.

• Brand Name: JUGGERKNOT 1.4MM SHRT W/NDLS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18038115
• Report Number: 0001825034-2023-02521
• Device Sequence Number: 7530948
• Product Code: MBI
• UDI-Device Identifier: 00880304509641
• UDI-Public: (01)00880304509641(17)260820(10)0002388152
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K110145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 08/20/2026
• Device Catalogue Number: 912068
• Device Lot Number: 0002388152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose