MAUDE Adverse Event Report: SYNTHES MONUMENT LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS; TRAY,SURGICAL INSTRUMENT

Catalog Number	690.504
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is not known.Device is an instrument and is not implanted/explanted.Concomitant devices therapy date is not known.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part # 690.504, supplier lot # lif025114.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition release to warehouse date: 15-may-2017.Supplier: (b)(6).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the bottom edges of the locking screw rack for tibial nail-ex implants are rough and sharp.The territory manager was lifting the locking screw rack from the trunk of the car and the locking screw rack cut him.It was approximately a 2-cm superficial cut.It bled, and was treated with a bandage.Patient did not see a doctor.Concomitant device reported: lid for locking screw rack for tibial nail-ex implants (part 690.505 , lot lif025114, quantity 1).This report is for one (1) locking screw rack for tibial nail-ex implants.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (locking screw rack for tibial nail-ex implants, part number 690.504, lot number lif025114).The subject device was returned to the manufacturer with the complaint condition stating: a sales consultant reported to the complaint handling unit on june 6th 2017 that the bottom edges of the 690.504 screw rack are rough and sharp.The territory manager was lifting the screw rack from the trunk of a car and the screw rack cut him.It was approximately a 2-cm superficial cut.Appropriate actions have been initiated/taken to address the matter.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6680890
• Report Number: 1719045-2017-10618
• Device Sequence Number: 13508028
• Product Code: FSM
• UDI-Device Identifier: 10886982254184
• UDI-Public: (01)10886982254184(10)LIF0251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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 Catalogue Number: 690.504
• Device Lot Number: LIF025114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95