MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; DERMATOME

Model Number 00-8801-001-00

Device Problems Failure to Cut (2587); Material Twisted/Bent (2981); Mechanics Altered (2984)

Patient Problems Laceration(s) (1946); Muscle/Tendon Damage (4532)

Event Date 01/12/2023

Event Type  Injury  

Event Description

Surgeon attempted to obtain a split-skin graft from a patient's arm during a surgical procedure with a zimmer air dermatome model 00-8801-001-00.First dermatome was set with 2in blade guard, zimmer 00-8800-000-10 blade, and set to cut.006in skin thickness.Nitrogen pressure input to device was set at 150 psi.On first pass, skin was not cut.A second pass was made with an inadequate, shredded graft.Blade was changed out for an identical one.Second pass did not cut any skin.Surgeon inspected the device and found that the leading edge of the blade guard was damaged with nicks and that blade guard appeared to be bent/warped and no gap was visible between the guard and the blade (a.006in gap should have been present).The air dermatome and blade guard were switched out with a new ones of the same model.Thickness was set to.008in with other parameters (2in guard blade, 150 psi nitrogen pressure) the same.The next pass cut skin but was too shallow, and the graft obtained was too thin and also shredded.The nitrogen pressure was increased to 180 psi.On this pass, the dermatome cut too deep, past subcutaneous fat and into muscle.Patient required two layers of sutures in soft tissue for primary closure.Manufacturer response for dermatome, na (per site reporter).We are sending in this device for repair.Manufacturer response for dermatome, na (per site reporter).Manufacturer response is pending device evaluation at their facility.

• Brand Name: NA
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 200 west ohio ave; dover OH 44622
• MDR Report Key: 16385217
• MDR Text Key: 309651602
• Report Number: 16385217
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-8801-001-00
• Device Catalogue Number: 00-8801-001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4015 DA
• Patient Sex: Male