MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CORPORATION DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the broken plate was not received for analysis, flower orthopedics was unable to fully evaluate the failure mode of the plate.The surgeon suggested that the failure of the plate may have been due to patient non-compliance (e.G., lifting a heavy object) during the healing process before the bone had fully healed.
Event or Problem Description
Company became aware of a device malfunction of a case that occurred in 2016 on (b)(6) 2020.The surgeon utilized a distal radius plate, dorsal (r), 9 holes to fix a fractured distal radius.A couple weeks after surgery, the patient came back to the doctor's office, with pain, to discover he had refractured his wrist and the plate had broken in half at one of the midshalf screw holes.The surgeon operated again to fix the broken wrist.He removed the broken hardware and used a similar plate from another company to do the revision.The patient had no further issues.

• Brand Name: DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): FLOWER ORTHOPEDICS CORPORATION; 100 witmer rd ste 280; horsham, pa
• MDR Report Key: 10454039
• Report Number: 3009996260-2020-00001
• Device Sequence Number: 16745154
• Product Code: HRS
• UDI-Device Identifier: 00840118103923
• UDI-Public: 00840118103923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: N/A
• Device Catalogue Number: FRP 432
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/26/2020
• 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: Other
• Patient Age: 56 YR