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

Model Number N/A

Device Problems Break (1069); Corroded (1131); Loose or Intermittent Connection (1371); Component Missing (2306); Calibration Problem (2890); Device Markings/Labelling Problem (2911); Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone: (b)(6).G2 foreign: united kingdom.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during maintenance that the following failure descriptions were noted: missing ce mark; control bar issue; calibration issue; broken screw; worn part number; worn screws; corroded bearing, reciprocation arm, e-ring; missing hinge sealing; loose swivel.When the surgeon used the dermatome, instead of taking a split skin graft, the depth gauge moved and a big chunk of tissue was taken.The surgeon stopped straight away, and a different dermatome was used.The event occurred during surgery.There was an unknown extension to the procedure time, because the surgeon had to repair the original injury, and an additional unplanned graft was required to complete the procedure.Due diligence is in complete; no further information is available at this time.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• 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 rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18563040
• MDR Text Key: 333465973
• Report Number: 0001526350-2024-00079
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose