MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER

Catalog Number 00770100000

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under: (b)(4).Unknown amount of delay during surgery.Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit was not locking in place.The event occurred during surgery.There was no harm but a delay was there during the event.No additional consequences were reported.

Event Description

Upon follow up, it was found that there was no harm and the delay was under 30 minutes.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: SKIN GRAFT MESHER
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8841373
• MDR Text Key: 152649443
• Report Number: 0001526350-2019-00597
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00770100000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4) ; CUTTER SN: (B)(4)
• Patient Outcome(s): Other