MAUDE Adverse Event Report: TRIMED, INC ULNAR OSTEOTOMY COMP PLATE SHORT

Model Number UOCP-S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, trimed was notified that two holes, of uocp-s plate, that take the saw guide were on the wrong side of the plate.The surgeon went to leave the plate in-situ, as the issue only came to light once the osteotomy was performed.The surgeon used a lag screw through the slotted hole instead, the osteotomy was stable.Trimed was notified by a distributor, (b)(4), in (b)(6).This event happened in a clinical setting, and this is the first event of its kind for the uocp-s plate.

• Brand Name: ULNAR OSTEOTOMY COMP PLATE SHORT
• Type of Device: ULNAR OSTEOTOMY COMP PLATE SHORT
• 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: annie cranston ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 7363139
• MDR Text Key: 103298826
• Report Number: 2031009-2018-00018
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00842188101533
• UDI-Public: 00842188101533
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UOCP-S
• Device Catalogue Number: UOCP-S
• Device Lot Number: 10003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1