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

Catalog Number 03.111.005

Device Problem Bent (1059)

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

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Phone number: (b)(6) manufacturing location: (b)(4).Manufacturing date: october 08, 2014.Neither deviation nor any non-conformance reports were marked in the device history record.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the depth gauge was used in a hallux valgus surgery on (b)(6) 2016 and the depth gauge did not move smoothly.It was difficult to use with one hand; specifically, the position around 20mm was hard to measure with.After the surgery, the device was checked and it was found the depth gauge was slightly curved.The device was bent to the opposite direction and it became movable.This is report 1 of 1 of for (b)(4).

Manufacturer Narrative

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.The report indicates that the: 03.111.005 / 9044892 manufacturing location: (b)(4).Manufacturing date: 24.Sep.2014.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.Device 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 Description

11/03/2016: updated information 2nd dhr provided for reporting.

Manufacturer Narrative

Device used for treatment, no diagnosis.The investigation showed the reported problem could not be reproduced during testing.Functional testing was completed and all parts moved as intended.Functional tests are required for multiple use devices prior to surgery.All movable parts must be oiled during maintenance after use.No product fault could be identified.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/2.4M 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6063422
• MDR Text Key: 58743357
• Report Number: 3003875359-2016-10561
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 9044892
• Other Device ID Number: (01)07611819356344(10)9044892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2014
• 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