MAUDE Adverse Event Report: ZIMMER, INC. GENDER SOLUTIONS PATELLO-FEMORAL JOINT PEG/TAIL DRILL; KNEE INSTRUMENT

Catalog Number 00592706000

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient's knee arthroplasty surgery was discontinued due to the device being absent from a loan kit.The patient was re-operated on four days later utilizing a loan kit containing all the relevant instruments.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed through information received regarding the event.Device history record review is not applicable, as the event is regarding an instrument missing from a surgical kit which is reassembled with reusable instruments after cleaning from previous procedures.Review of complaint history found no other reports of this nature for the reported part number.It was stated the surgeon was made aware the drill was missing prior to commencement of the procedure; the decision was made to proceed inspite of the missing item.The bill of materials for surgical kits is created by (b)(4) to meet (b)(4) and other global guidelines; however, the bill of materials can be amended by the (b)(4).The drill was not identified by customer services as missing upon receipt of the kit, as the drill was not included in the required items specified in the bill of materials for the kit.The root cause of the drill not being present in the case cannot be determined as it is unknown who modified the bill of materials for this case.The cause of the case being stopped mid procedure, and the patient being reopened at a later date is due to the surgeon proceeding without the required drill.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.

• Brand Name: GENDER SOLUTIONS PATELLO-FEMORAL JOINT PEG/TAIL DRILL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6026591
• MDR Text Key: 57323134
• Report Number: 0001822565-2016-03683
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00592706000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention