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
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 03.113.025, lot # 3665631: manufacturing site:(b)(4), manufacturing date: 28.Jan.2011: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service history review was performed for part # 03.113.025, lot # 3665631: no service history review can be performed as part number 03.113.025 with lot number(s) 3665631 is a lot/batch controlled item.The manufacture date of this item is 1-feb-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 an insertion screw for an insertion handle is missing.No patient involvement reported.This report is for one (1) insertion handle.This is report 1 of 1 for complaint com-(b)(4).
Additional Manufacturer Narrative
A service and repair evaluation was performed on subject device.The customer reported the insertion 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 1-jun-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: 6619838
• Report Number: 3003875359-2017-10274
• Device Sequence Number: 16166906
• Product Code: HTJ
• UDI-Device Identifier: 10886982072917
• UDI-Public: (01)10886982072917(10)3665631
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: 3665631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1