MAUDE Adverse Event Report: TRIMED, INC SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM

Model Number	L5556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed received the following report on (b)(6) 2018 from trimed sales member located in australia, regarding the self-drill cannulated compression screw l thd 5.5, 56mm: during a intra-operative procedure, it was discovered that the self-drill cannulated compression screw l thd 5.5, 56mm (l5556) had the screw end snap off halfway through inserting into the bone.All parts of the screw were recovered from the patient.It was determined that the bone was quite sclerotic compared to usual.This incident did not cause any further harm to the patient.This is the first time this type of malfunction has been reported to trimed.

• Brand Name: SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM
• Common Device Name: SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM
• 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: 7987523
• Report Number: 2031009-2018-00047
• Device Sequence Number: 2496546
• Product Code: HWC
• UDI-Device Identifier: 00842188103681
• UDI-Public: 00842188103681
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: L5556
• Device Catalogue Number: L5556
• Device Lot Number: 93277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• 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