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

Catalog Number 00515048200

Device Problems Battery Problem (2885); Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the battery pack had split and there was a black dust visible in the packaging.An alternate device was used in the event.No patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Dhr review: the device history record (dhr) for 00515048200, lot number z000011108, 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 (b)(6) 2019, it was reported from (b)(6) hospital that the battery pack had split and there was a black dust visible in the packaging.On 20 may 2019, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the device battery had ruptured within the sterile packaging.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: although the reported event was confirmed, it cannot be specifically determined from the information provided what caused the batteries to rupture.Therefore, the root cause could not 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.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

Event Description

No additional event information available.

• 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: 8545646
• MDR Text Key: 142943698
• Report Number: 0001526350-2019-00273
• 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: 09/12/2019

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: 02/28/2021
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000011108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1