MAUDE Adverse Event Report: TRIMED, INC. LOCKING PLATE, CURVED A, 8-HOLE

Model Number	PCA8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed received the following report of (b)(6) 2018 from trimed sales member located in the united states, regarding the locking plate, curved a, 8-hole: during a post-operative x-ray scan, it was discovered that locking, curved a, 8-hole (pca8) had broken and would need to be explanted on (b)(6) 2018.Trimed has contacted the sales member more than three times to gether further information regarding this complaint and the attempts have been unsuccessful.This is the first time this type of malfunction has been reported to trimed for this plate.

• Brand Name: LOCKING PLATE, CURVED A, 8-HOLE
• Common Device Name: LOCKING PLATE, CURVED A, 8-HOLE
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita, ca
• Manufacturer (Section G): TRIMED, INC; 27533 avenue hopkins; santa clarita, ca
• Manufacturer Contact: annie cranston ; 27533 avenue hopkins; santa clarita, ca ; 2548485
• MDR Report Key: 7987517
• Report Number: 2031009-2018-00045
• Device Sequence Number: 16768338
• Product Code: HRS
• UDI-Device Identifier: 00842188100765
• UDI-Public: 00842188100765
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: PCA8
• Device Catalogue Number: PCA8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• 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: 10/19/2018
• Supplement Report FDA Received Date: 10/19/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown