MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS; GAUGE, DEPTH

Catalog Number 03.111.005

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.Dhr review for 03.111.005 / 7598175; manufacturing location: (b)(4); manufacturing date: 24.Nov.2011.No 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the reported device was used in surgery for distal radius fracture on (b)(6) 2017.The surgeon used va-lcp (variable angle locking compression plate).The surgeon complained that during surgery, there was a malfunction at the depth gauge.The depth gauge didn¿t work smoothly at all and the surgeon struggled with measuring screw.The surgeon tried to clean it with physiological saline solution several times but it didn¿t get any better.There is no information available about patient and surgical outcome.There was a surgical prolongation of 10 minutes reported.This complaint involves 1 part.Concomitant device: 1x unk va-lcp.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The returned depth gauge was tested and the complaint condition could be confirmed, as it was rough running as reported.Investigation of documentation for production and material gives evidence that the instrument was produced under specifications in nov, 2011.Failure in material or production could not be detected.The instrument was lubricated with synthes special oil during the investigation and was then freely movable as required.The problem as per complaint description could not be duplicated anymore.Therefore we assume that the instrument was not lubricated as per the instructions provided by the manufacturer.As per the leaflet ¿important information¿ moving instrument parts, e.G.Joints, sliding parts, dismountable threaded connections etc.Must be regularly lubricated.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.No indication for product related issue was found.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 GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6336308
• MDR Text Key: 67599368
• Report Number: 3003875359-2017-10066
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819356344
• UDI-Public: (01)07611819356344(10)7598175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.111.005
• Device Lot Number: 7598175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X UNK VA-LCP