MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.01

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted / explanted.Service history review could not be performed as part # 319.01, lot # 9685157 is a lot/batch controlled item.The release to warehouse date of this item is feb 03 2016.The service history review is unconfirmed.Device history record review was completed for part # 319.01, lot # 9685157, manufacturing location: (b)(4) , manufacturing date: 26.Jan.2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

This report is for a veterinary complaint.It was reported that routine post-operative radiographs revealed improper screw lengths were used on multiple veterinary patients that underwent unspecified surgical procedures.The device was checked and believed to be inaccurate; the measurement was off by approximately two millimeters.It was reported that there were no surgical delays or other medical interventions required.All procedures were completed successfully and the patients had fully recovered.No negative patient outcomes were noted at the time of the report.Concomitant devices reported: screw (part# unknown, lot# unknown, quantity: unknown).This report is for one (1) depth gauge for 2.7mm & small screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Labeled for single use? 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the depth gauge(part number 319.01, lot number 9685157).The subject device was returned with the complaint condition stating a very slight bend was observed on the distal end of the measuring hook.This is consistent with plastic deformation as a result of an applied bending force.The condition is not fully consistent with the reported condition in that the device does measure as intended.The device is designed to be used through the plate and to account for the plate thickness in the measurement reading.The complaint was confirmed.A device history record (dhr) review, visual inspection, functional test, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The device was initially received at service and repair.The repair technician reported the tip of the gauge was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The evaluation was confirmed.No non-conformance records were generated during production.The device is comprised of four components (slider assembly, guide sleeve, knurled cap, and headpiece assembly) that disassemble for decontamination.All components were received.The measuring needle was found to be within the specification of 79.2mm +/-0.3 at 79.4mm.Functional testing of the measuring feature determined that the depth gauge functions as intended.All dimensional inspections completed with calipers.The device is designed to be used through the plate and to account for the plate thickness in the measurement reading thus, as no functional issue was identified, the "does not/will not function: will not measure" condition for this device is unconfirmed and could not be replicated.A review of the current design drawing / manufactured revision for the top level assembly, the slider assembly, the knurled cap component, the headpiece assembly component, and the guide sleeve component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The condition is not fully consistent with the reported condition in that the device does measure as intended.The bend in the 319.01 needle is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the plastic deformation limit of the material and would not be expected when used as recommended.It should also be noted that the device is designed to be used through the plate and to account for the plate thickness in the measurement reading.Given the unknown circumstances at the time of the issue and during subsequent checking of the device, the root cause could not be definitively determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Service history review was performed for part # 319.01, lot # 9685157.The customer reported the gauge did not work properly.The repair technician reported the tip of the gauge was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL 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: 6021283
• MDR Text Key: 57186646
• Report Number: 3003875359-2016-10535
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.01
• Device Lot Number: 9685157
• Other Device ID Number: (01)10886982189950(10)9685157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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: UNKNOWN QUANTITY OF UNKNOWN SCREW