MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUPORT; CANNULA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, zimmer was notified that in (b)(6), an accuport drill tip has been left behind in the patient after the subchondroplasty procedure.There was a 10 minute delay noted due to the decision of whether or not to leave the device within the patient.The product was not returned for the investigation.Once additional information becomes available, an additional report will be submitted.
Event or Problem Description
The accuport fractured and the drill tip remained implanted.
Event or Problem Description
The accuport fractured and the drill tip remained implanted.
Additional Manufacturer Narrative
On (b)(6) 2019, during a subchondroplasty surgery, the accuport® cannula (part number 307.032 and lot number 40004) was drilled into the bone and the accufill was injected through the cannula.For removal of the accuport®, the cannula was pulled back a little, and the plunger was reinserted.It was noted during surgery that the plunger could not be fully inserted in the cannula.Then the cannula was removed by hand by slightly oscillating.When the cannula was fully removed, it was observed that the tip of the cannula was broken off at the location of the fenestrations and had remained in the patient.The decision was made by the health care professional after a long consideration to leave the cannula tip inside the patient, as the surgery was determined to be successful.It was reported that pictures of the drill tip were taken, but the sales representative could not retrieve them from the hospital.The sales representative also reported that postoperatively, the patient is doing very well and whether the tip will be removed at any time in the future remains to be seen.No product was returned for evaluation, as it was discarded by the hospital and the fragment remains implanted in the patient, therefore a definitive root cause cannot be determined.Based on the information collected during the investigation, the complaint is most likely due to incorrect removal technique during the procedure.Per the accuport ifu, use proper technique to remove cannula from bone to avoid damaged or broken cannula.Fully insert stylus into cannula, then remove stylus and cannula with surgical drill in reverse.This technique was reviewed with the sales representative.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.A retain was evaluated for the same raw material lot (40044) and there were no abnormalities noted that may have contributed to the complaint condition.

• Brand Name: ACCUPORT
• Common Device Name: CANNULA
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9495229
• Report Number: 3008812173-2019-00055
• Device Sequence Number: 1202927
• Product Code: FGY
• UDI-Device Identifier: 00889024205116
• UDI-Public: 00889024205116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: N/A
• Device Catalogue Number: 307.032
• Device Lot Number: 40004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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
• Outcome Attributed to Adverse Event: Other