MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 5CC 11G; FILLER, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant 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.
Event or Problem Description
It is reported that during a subchondroplasty procedure to address a lesion on the talus, the accuport cannula was identified to have been fractured.An x-ray was taken and the missing piece was identified within the talus.Multiple attempts were made to remove the fragment, however, the surgeon was unable to remove the remaining portion.There were no additional complications reported and the subchondral injection was able to be completed successfully into the lesion.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.The results of the investigation are as follows: visual inspection of the returned component noted it to exhibit signs of repeated use (nicked and gouged) and the threaded end is fractured.All pieces were not returned.The complaint is confirmed.A dimensional evaluation noted the product dimensions are conforming to specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.This device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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
No further event information available at the time of this report.

• Brand Name: KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 5CC 11G
• Common Device Name: FILLER, BONE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 11059144
• Report Number: 3008812173-2020-00023
• Device Sequence Number: 16819256
• Product Code: OJH
• UDI-Device Identifier: 00889024205376
• UDI-Public: (01)00889024205376
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 03/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 514.503
• Device Lot Number: KC06746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 06/07/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR