MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. AIR DERMATOME HANDPIECE

Model Number N/A

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Laceration(s) (1946)

Event Date 09/14/2015

Event Type  Injury  

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

It was initially reported that the device had a thickness adjustment failure which led to muscle damage.Additional clinical information determined that the issue occurred during surgery when the device took too deep of a cut and damaged the muscle of the patient.An alternate device was retrieved and used to complete the procedure with a delay of approximately 5 minutes.

Manufacturer Narrative

Device was manufactured on 11/21/1997 and has no repair history at zimmer biomet surgical since july of 2011.Investigation revealed the thickness control lever was loose.There was also damage to the head, control bar, neck and housing shaft.Prior to repair, the device operated within motor speed specifications.The device met calibration and side to side specifications at all tested thickness settings.Repair of the device included replacement of the thickness control lever, head, control bar, neck, housing shaft and standard repair parts.Post repair analysis revealed corrosion to the head, housing shaft, neck and bearings.The customer's reported event was not reproduced during testing; however, was most likely due to the loose thickness control lever, which was most likely due to wear through use over time.The customer should be aware, per the instructions for use, ¿the zimmer air dermatome should be returned every 12 months and the hose every 6 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy.¿ the device was repaired and returned to the customer.Recommended actions: recommended actions from ¿zimmer¿ air dermatome instruction manual¿ 06001810406 rev.12-10 to avoid serious injury to the patient and operating staff while the zimmer air dermatome is in use, the user must be thoroughly familiar with its function, application and instructions for use.The handpiece and accessories must be inspected prior to each use.Visually inspect for damage and/or wear.Always inspect the handpiece carefully for possible scratches, nicks, or burrs caused by extended use or mishandling.Check the action of moving parts to ensure smooth operation throughout the intended range of motion.The zimmer air dermatome should be returned every 12 months and the hose every 6 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy.Note: if damage or wear is noted that may compromise the function of the instrument, do not use.Handle the zimmer air dermatome carefully.Should it be inadvertently dropped or damaged, it should be returned for service.

• Brand Name: AIR DERMATOME HANDPIECE
• Type of Device: AIR DERMATOME HANDPIECE
• 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: jennifer hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5195586
• MDR Text Key: 30164396
• Report Number: 0001526350-2015-00173
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• 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: 00-8801-001-00
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1