MAUDE Adverse Event Report: ZIMMER SURGICAL, INC.; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The event recorded by zimmer biomet under (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.[mw5084755].Device evaluated by mfr: not returning.

Event Description

It was reported that patient underwent surgery to remove the broken fragment of the hemovac drain kit catheter which was retained during the removal process of the drain by surgeon.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) review could not be performed as a part number nor lot number was provided for the reported event.The complaint history review could not be performed as a part number nor lot number was provided for the reported event.On 21 mar 2019, it was reported from upmc corporate risk management that that the patient underwent a bedside drain removal complicated by a retained piece of fractured catheter, which required surgical removal fractured retained catheter was in the fascia.The doctor met a lot of resistance and continued to pull on the drain.It stretched and snapped.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Not returned by customer.

Event Description

No additional event information.

• Brand Name: UNK
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8471187
• MDR Text Key: 140543960
• Report Number: 0001526350-2019-00209
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 73