MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

Model Number N/A

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, the product return and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during the surgery, this product made abnormal noise during working.And the customer noticed a burnt smell from this product.There was no harm to the patient and no delay in the procedure as a result of the device malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.D4: (b)(4).Reported issue: it was reported that during the surgery, this product made abnormal noise during working.Dhr review: this investigation is being completed as a limited investigation as no problem was found with the device.Therefore the complaint history and dhr reviews are not required.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) that during the surgery, this product made abnormal noise during working.On 09 october 2019, a returned product investigation was performed on the 00515048201.The physical evaluation revealed no problems with the device and it was noted that the device was functioning as intended.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event could not be duplicated during inspection of the device, and the device was noted to be functioning as intended.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

• Brand Name: HIP KIT
• Type of Device: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9153267
• MDR Text Key: 163549095
• Report Number: 0001526350-2019-00838
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 64302704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1