MAUDE Adverse Event Report: TRIMED INC SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM

Model Number	SWOR-7M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A trimed distributor from (b)(6), notified trimed on 05 dec 2021 that a swor-7m had broken and needed to be removed from the patient.The date believed to be the date of removal was (b)(6) 2021.It is currently believed that the break in the plate was caused by a nonunion, however additional information has been requested with no response yet.This device was implanted for approximately 3 months before the break was detected in an x-ray which prompted the removal of the device.It is currently believed that the patient has since started healing well, however additional information has been requested with no response yet.Additional information was requested on the following dates, 06 dec 2021, 09 dec 2021, 14 dec 2021, 16 dec 2021, 28 dec 2021 and 03 jan 2022, with no additional information provided as of 04 jan 2022.
Event or Problem Description
A trimed distributor from (b)(6) medical located in china, notified trimed on (b)(6) 2022 that the plate had not broken due to a nonunion but more likely the plate broke due to the patient not following the correct after care instructions.It was determined that the patient had been participating in sports which caused the patient to fall and re-break the plate and bone.

• Brand Name: SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM
• Common Device Name: SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM
• Manufacturer (Section D): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: stephanie rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 13322318
• Report Number: 2031009-2022-00001
• Device Sequence Number: 1673944
• Product Code: HRS
• UDI-Device Identifier: 00842188101458
• UDI-Public: 00842188101458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: SWOR-7M
• Device Catalogue Number: SWOR-7M
• Device Lot Number: MX20007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown