MAUDE Adverse Event Report: ZIMMER SPINE INSTINCT JAVA BLOCKER; INSTINCT JAVA SYSTEM

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3003853072-2021-00024 to 3003853072-2021-00035.
Event or Problem Description
It was reported that the threads of 12 plugs stripped during an operation.The plugs were replaced with new plugs.There was no reported impact to the patient.This is report three of twelve for this event.
Event or Problem Description
It was reported that the threads of 12 plugs stripped during an operation.The plugs were replaced with new plugs.There was no reported impact to the patient.This is report three of twelve for this event.
Additional Manufacturer Narrative
Corrected information in h3 added information to h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for twelve (12) of twelve (12) returned instinct java blockers (pn 046w0an00002) for the failure of stripped threads.Medical records were not provided for review.Device evaluation: visual inspection of the devices reveals that all returned closure tops have stripped threads.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear cross-threading during use.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: INSTINCT JAVA BLOCKER
• Common Device Name: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 11616280
• Report Number: 3003853072-2021-00026
• Device Sequence Number: 11544490
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)V16002717(11)170210
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN00002
• Device Lot Number: V16002717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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