MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT; GAUGE,DEPTH

Catalog Number	03.113.025
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date component went missing is not known.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.No service history review can be performed as part number 03.113.025 with lot number(s) 3665633 is a lot/batch controlled item.The manufacture date of this item is 2-feb-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Manufacturing location: (b)(4).Manufacturing date: 02 february 2011.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 is reported the insertion handle is missing the connection screw component.Issue was discovered during inspection of the device.No patient or surgical involvement.This report is for one (1) insertion handle this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A service and repair evaluation was performed on the subject device.The customer reported the connecting screw was missing.The repair technician reported the screw was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: m3.5 screw.The item was repaired per the inspection sheet, passed synthes final inspection on 31-may-2017 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.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.

• Brand Name: INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT
• Common Device Name: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6533556
• Report Number: 3003875359-2017-10209
• Device Sequence Number: 10855030
• Product Code: HTJ
• UDI-Device Identifier: 10886982072917
• UDI-Public: (01)10886982072917(10)3665633
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/04/2017

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: 03.113.025
• Device Lot Number: 3665633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1