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

Catalog Number 00770100000

Device Problem Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It was reported that the unit handle got stuck, and the handle was damaged.There were scraps on the handle port from maybe wear.The event occurred during preparation.There was no harm reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Reassessed as not reportable: upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

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: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8760182
• MDR Text Key: 150011988
• Report Number: 0001526350-2019-00527
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• 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: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1