MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM

Catalog Number	03.019.029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.(b)(6).A device history record (dhr) review was performed on part # 03.019.029, lot # 8532062: manufacturing location: (b)(4), manufacturing date: 06.Aug.2013.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the reported device was supposed to be used in surgery for humerus diaphysis fracture on (b)(6) 2017.However, the tip of a depth probe was broken when the surgeon checked it before surgery.There was no patient harm; no other medical intervention was required.No information is available about surgical prolongation.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A manufacturing investigation action was conducted/performed.The report indicates that the: 1x article 03.019.029 with lot 8532062 / length probe f/multiloc hum nail system received (1) article of length probe f/multiloc hum nail syst, art.No.: 03.019.029, for manufacturing investigation.The article is in a used condition.The wire for measuring head is broken off.Received and forwarded to the manufacturing plant for investigation.Component wire for measuring head 60065641 is broken off at the laser welding seam.The wire for measuring head is connected by laser welding with component shaft ø6 60073078.The inner and outer diameters of the connection have been measured and they are within specification.According to the manufacturing investigation none indication of a production failure could be found.On component shaft: ø6 60073078 is a deformation/damage of the front side surface visible.It seems that the damage weaken the laser welding seam and caused the breakage of the device.It has been determined that the damage on the shaft ø6 60073078 occurs after production during use and is caused by mishandling.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable 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: DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: PROBE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6428592
• Report Number: 3003875359-2017-10138
• Device Sequence Number: 16222717
• Product Code: HXB
• UDI-Device Identifier: 07611819462311
• UDI-Public: (01)07611819462311(10)8532062
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017

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: 03.019.029
• Device Lot Number: 8532062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1