MAUDE Adverse Event Report: ZIMMER MEDIZINSYSTEME GMBH EMFIELD; Stimulator, muscle, powered

Model Number	5038
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The device has been used with a known defective spherical joint in the applicator arm.The joint broke, the applicator fell down and the arm bounced up through the force of a gas pressure spring.A bystander was hit by the arm and received a laceration at the forehead.The wound has to be stitched.
Additional Manufacturer Narrative
(1) the device has been used with a known defective spherical joint in the applicator arm.The joint broke, the applicator fell down and the arm bounced up through the force of a gas pressure spring.(2 ) a bystander was hit by the arm and received a laceration at the forehead.The wound has to be stitched.(3) a new arm which was already shipped to the hcp before the incident was installed.(4) the ball in the shperical joint showed signs of tear and wear.The customer noticed the damage and ordered a new applicator arm for replacement.The new arm has been delivered prior to the incident but was not installed.The damage in the spherical joint was most probably caused by moving the joint without opening the fixation lever.Further usage lead to a sudden fracture of the joint.

• Brand Name: EMFIELD
• Common Device Name: Stimulator, muscle, powered
• Manufacturer (Section D): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• Manufacturer Contact: stefan leinweber ; junkersstrasse 9; neu-ulm, bavaria 89231 ; GM 89231
• MDR Report Key: 18902515
• Report Number: 0008010720-2024-01671
• Device Sequence Number: 13024080
• Product Code: IPF
• UDI-Device Identifier: 04053815078562
• UDI-Public: 04053815078562
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5038
• Device Catalogue Number: 5038
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female