MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC STERILE JOINT PREP INST KIT ORTHOLOC2 JOINT PREP; OSTEOTOME

Model Number	9914PK01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that there were two joint prep kits and the 2.5 drills both got stuck in the drill guide.The surgeon was extra careful after the first one got stuck and the second drill still got stuck in the second drill guide.
Additional Manufacturer Narrative
The reported event could be confirmed since an image provided does show the drill has jammed in the guide barrel.However, no conclusion can be drawn based on the image alone.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there were two joint prep kits and the 2.5 drills both got stuck in the drill guide.The surgeon was extra careful after the first one got stuck and the second drill still got stuck in the second drill guide.The drill seems to get jammed into the drill guide, with the second joint prep kit the surgeon even made sure she didn't press down into drill guide or go off angle and the drill still got stuck into the drill guide.No debris the drilling was stopped as soon as the drill got jammed.Event was resolved by the use of a different drill and drill guide from the variax set.Midfoot fusion was the indication and/or diagnosis that led to this patient¿s procedure.Patient had normal bone quality.No medical interventions, surgical delays, or additional patient adverse consequences.No other instruments/implants were used in combination with the affected instruments that may have contributed to this event.

• Brand Name: STERILE JOINT PREP INST KIT ORTHOLOC2 JOINT PREP
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15887007
• Report Number: 3010667733-2022-00413
• Device Sequence Number: 5122742
• Product Code: HWM
• UDI-Device Identifier: 00889797076869
• UDI-Public: 00889797076869
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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 Model Number: 9914PK01
• Device Catalogue Number: 9914PK01
• Device Lot Number: 1716631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Male