MAUDE Adverse Event Report: BIEDERMANN MOTECH, INC. MDS PLATING SYSYEM; NARROW PLATE, 3.5T, 10 HOLE

Model Number	MDS1101N10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via e-mail on (b)(6) 2021 that a revision surgery was needed to remove a broken 10 hole narrow plate.The plate was broken in half and safely removed from the patient.On (b)(6) 2021 the reporter stated via phone call that the patient reported she woke up in pain as if her arm was broken.When she got to the hospital it was discovered that the plate was broken in half.There are no images of the event.It was described the broken plate was not pre bent and was located below the surgical neck of the humerus, between the olecranon.The plate and screws were removed with no issues.There are no reports of delays or impact on the patients outcome as a result of the revision surgery.Subject items will not be returned.The revision surgery included removing the broken plate and replacing it with 2 3.5t narrow plates, a 8 hole narrow plate and 10 hole narrow plate.

• Brand Name: MDS PLATING SYSYEM
• Common Device Name: NARROW PLATE, 3.5T, 10 HOLE
• Manufacturer (Section D): BIEDERMANN MOTECH, INC.; 7620 nw 25 st; suite 3 & 4; miami FL 33122
• MDR Report Key: 12572501
• Report Number: 3009222247-2021-00012
• Device Sequence Number: 5997175
• Product Code: HRS
• UDI-Device Identifier: 10812269023556
• UDI-Public: (01)10812269023556
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MDS1101N10
• Device Catalogue Number: MDS1101N10
• Device Lot Number: INFROMATION NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention