MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. H.A.S. KIT WITH 1/8" DRAIN 3,2MM 10FR PVC; HEMOVAC AUTOTRANSFUSION SYSTEM, 1/8" DRAIN

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returning to the manufacturer for evaluation as it is an internal component.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported that the patient had a total shoulder arthroplasty on (b)(6) 2016 and the physician placed a drain in the incision.The physician pulled the drain out the next morning (b)(6) 2016) and it broke with a piece still in the patient.Patient returned to surgery on (b)(6) 2016 to remove the remaining piece of the drain; neither physician nor the surgery staff retained the piece of the drain for further evaluation.

Manufacturer Narrative

The device was returned to the manufacturer; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

Additional information received from the customer on (b)(6) 2016 stated that the reported issue occurred the morning after a surgical procedure when the product was removed; the device broke with a piece still in the patient.There was a medical intervention/additional surgical procedure was required for reopening or revisiting of surgical wound for removal of device or product.The surgical technique for the product was utilized.

Manufacturer Narrative

Conclusion detail: a device history records (dhr) review was performed for part number 00-2555-020-05, lot 63182496.This device was manufactured and placed into inventory on dec 1, 2015.There were no reported non-conformances or relevant request for deviations (rfds) or engineering change notices (cns) noted on the dhr.Product number 06-0020-013-65, 125¿ od x.0625¿ id x 42¿ length.1/8¿ drain, rad.From lot number 63137019 was used on the above assembly.These parts were manufactured and placed into inventory on aug 22, 2015.There were no reported non-conformances or relevant rfds or cns noted on the dhr.No product was returned for evaluation.It was reported that the patient had a total shoulder arthroplasty on (b)(6) 2016 and the physician placed a drain in the incision.The physician pulled the drain out the next morning and it broke with a piece still in the patient.Patient returned to surgery on (b)(6) 2016 to remove the remaining piece of the drain.Neither physician nor the surgery staff retained the piece of the drain for further evaluation.Without the actual device for evaluation and with just the available information the event cannot be confirmed and determination of a specific root cause for the breakage is not possible.The drawing requirement for the perforated drain specifies a tensile breaking strength for the tubing at 20.0 pounds per square inch and 9.0 pounds per square inch at the perforations.All testing for the tubing was performed and was acceptable for the reported lots.There are too many unknown factors that could account for the drain breaking.Most likely, the drain was either placed and arranged in the wound site or removed from the wound site using a surgical instrument.The instrument could have weakened the tubing¿s tensile strength where it clamped onto the tube.Most likely the drain broke at a perforation which is the weakest area of the tubing.In addition, the use of an instrument to remove the drain can make it difficult for the user to maintain an even tension and cause the pull pressure to exceed the 9.0 pounds per square breaking strength at the perforations.Recommended actions: none - severity and frequency do not warrant further actions.

• Brand Name: H.A.S. KIT WITH 1/8" DRAIN 3,2MM 10FR PVC
• Type of Device: HEMOVAC AUTOTRANSFUSION SYSTEM, 1/8" DRAIN
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 5736093
• MDR Text Key: 47750855
• Report Number: 0001526350-2016-00066
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK920273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00255502005
• Device Lot Number: 63182496
• Other Device ID Number: 00889024021563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR