MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULS PLUS HIP KIT; LAVAGE, JET

Catalog Number 00515048201

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The customer has indicated that the device is in process of being returned for evaluation and the investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that during the surgery, water pressure of this product was lower than normal one.The surgeon tried to use this product for the surgery, but the hand-piece of this product abnormally generated heat.So, the surgeon stop using this product.The battery cable has been already cut off when we received this complaint product.The batteries showed signed of expulsion.No adverse events were reported as a result of this 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.The following sections were updated/corrected: d4: (b)(4).Reported issue: it was reported that during the surgery, water pressure of this product was lower than normal one.Dhr review: the device history record (dhr) for 00515048201 lot number 28576610, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on 05 august 2019, it was reported from kobe university hospital that during the surgery, water pressure of this product was lower than normal one.On 05 august 2019, a returned product investigation was performed on the 00515048201.The physical evaluation revealed that the device was returned with the battery pack cable cut and a returned product investigation could not be completed.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event could not be confirmed as the device was returned with the battery pack cut.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: PULS PLUS HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8920655
• MDR Text Key: 155213485
• Report Number: 0001526350-2019-00679
• 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: 09/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 00515048201
• Device Lot Number: 28576610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1