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

Model Number N/A

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that during the surgery, it was found that the product looked like exploded inside of the sterile package when the nurse opened the box.An alternate device was used for the surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the device history record for 00515048201 identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured.The sterile packaging was still sealed.This complaint is confirmed.Using view 3.2 from the etq reliance system, from (b)(6) 2016 to (b)(6) 2017, there were 28 closed complaint that used rmf-130 rev.10, line #59, or the respective item from the previous revision, 3.3.9, as part of their respective risk assessment.The scope of this search includes all part numbers contained within rmf-130 line item.(b)(4).The calculated p1 value is consistent with the current associated rmf file.A review using the p/n of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿explode¿ between (b)(6) 2016 to (b)(6) 2017, resulted in 3 complaint.A review using the criteria of p/n and complaint category of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿explode¿ and sorted by manufacturer date was performed.This review resulted in the highest occurrence for a given manufacture date was 1.Reviewing the complaints for the shows 1 complaints for this part and lot number.The root cause of the reported event is a short circuit of the unit.However, the source of this short circuit could not be determined due to the extent of the damage of this unit.Hhed 09-2017-001 was created to address the length of the wires inside the battery pack in order to eliminate the need to fold them, reducing the likelihood of a short circuit.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7183943
• MDR Text Key: 97059539
• Report Number: 0001526350-2018-00030
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: Z000007990
• Other Device ID Number: (01) 00889024375192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1