MAUDE Adverse Event Report: TRIMED, INC WRIST HOOK DORSAL IMPACTOR

Model Number	IMPCT-WHD
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, (b)(6) reported that a wrist hook dorsal impactor (impct-whd) was found to have shown signs of rust on the handle.The nonconforming part was found during a tray replacement inspection and had no contact with a patient.This is the fourth time that this type of malfunction has occurred for this part.

• Brand Name: WRIST HOOK DORSAL IMPACTOR
• Common Device Name: WRIST HOOK DORSAL IMPACTOR
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7520554
• Report Number: 2031009-2018-00024
• Device Sequence Number: 16490317
• Product Code: LXH
• UDI-Device Identifier: 00842188113659
• UDI-Public: 00842188113659
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: IMPCT-WHD
• Device Catalogue Number: IMPCT-WHD
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1