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

Model Number	N/A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified one pulsavac product was received, not in the original packaging.Visual inspection found that the handpiece was returned with the electrical cables and tubing sheared off.The blue tip lock was returned detached from the assembly.The tip lock, when reattached to the handpiece, seemed to manually function properly.There reported complaint was confirmed as a visible void was identified in the handpiece mating parts at the tip end, where it did not close.Functional testing could not be completed due to the cut cables.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
Event or Problem Description
It was reported that during surgery the pulsavac plus ac hip kit malfunctioned.The customer reported that during normal use the blue clamps and the attachment of the device loosened.During the investigation, it was discovered that the cord was cut.No adverse event was reported as a result of this malfunction.

• Brand Name: PULS PLUS AC HIP KIT
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10608774
• Report Number: 0001526350-2020-00826
• Device Sequence Number: 11498305
• Product Code: FQH
• UDI-Device Identifier: 00889024375208
• UDI-Public: (01)00889024375208(17)211031(10)29518689
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00515048601
• Device Lot Number: 29518689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1