MAUDE Adverse Event Report: SYNTHES BETTLACH DEPTH GAUGE FOR MINI SCREWS; GAUGE, DEPTH

Catalog Number 319.11

Device Problems Incorrect Measurement (1383); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

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 number 319.11 with lot number(s) 9567797 is a lot/batch controlled item.The release to warehouse date of this item is 3-aug-2015.The service history review is unconfirmed.Device history record review was completed for part # 319.11, lot # 9567797, manufacturing location: (b)(4), manufacturing date: jul 28, 2015.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.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 the depth gauge did not work properly.The measurement was off by approximately two millimeters.The device also appeared to be missing a "collar".There was no patient involvement.This report is for one (1) depth gauge for mini screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Additional narrative: service history review was completed for part # 319.11, lot # 9567797.The customer reported the gauge did not work properly and the collar was missing.The repair technician reported the nose piece and sleeve were missing.Missing parts 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.It was confirmed that 319.110.500 scale body complete lot 9274929 is component of part # 319.110, lot 9567797.Manufacturing location: (b)(4), manufacturing date: feb 18, 2015.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.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

Additional narrative: device was used for treatment, not diagnosis.A product development investigation was performed for the depth gauge (part number 319.11, lot number 9567797).The subject device was returned with the complaint condition stating the headpiece, and guard sleeve were not returned, and the ball and coil spring were found to be missing from the slider.The measuring hook is slightly deformed at the distal end.The proximal end of the guide sleeve is slightly deformed where the measurements are taken.The slider/measuring hook assembly, guide sleeve, and knurled cap were returned.The slider/measuring hook assembly (lot 9274929) was confirmed to be built as a component of the depth gauge assembly 319.110 / lot 9567797.The device was confirmed to be missing the headpiece and guard sleeve, and the ball and coil spring were found to be missing from the slider.The complaint was confirmed.The allegation regarding the measurement being inaccurate by 2mm is not able to be confirmed.There is minor post manufacturing damage observed to the measuring hook and the guide sleeve.Despite this, the measuring hook was found to be the correct length and the guide sleeve measured only 0.02mm above specification at the largest point.This is unlikely to contribute to a 2mm discrepancy in the overall measurement.A visual inspection, dimensional test, complaint history review, drawing review, dhr review and risk assessment review were performed as part of this investigation.No non-conformance records 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.Drawings were reviewed.The drawings are current and were in use during the time of manufacture of the product.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed.Two length measurements of the guide sleeve were taken.1 to the deformed site (measurement site), and 1 to a nondeformed site.The sleeve measures 42.21 mm at the non-deformed site, which is within specification of 42.2 +/- 0.2.Sleeve measures 42.42 mm at the deformed site (measurement site), which is not within specification of 42.2 +/- post manufacturing damage is suspected.Measuring hook measures 54.33 mm which is within the specification of 54.2mm +/- 0.3.The measuring hook to the '20' mark on the slider measures 87.19mm which is within the specification of 87.2mm +/- 0.1.All were measured using mitutoyo caliper no definitive root cause was able to be determined for the missing components, as the device usage is unknown.It is likely that the headpiece and guard sleeve were misplaced or lost between uses.No definitive root cause was able to be determined for the inaccurate measurements, as there were no dimensional issues observed that would contribute to a 2mm reading discrepancy.It is likely that human error may have played a role in reported the measurement issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Brand Name: DEPTH GAUGE FOR MINI SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6022107
• MDR Text Key: 57196995
• Report Number: 9612488-2016-10416
• 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: 319.11
• Device Lot Number: 9567797
• Other Device ID Number: (01)10886982190024(10)9567797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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