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

Catalog Number 319.01

Device Problems Break (1069); Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Pt identifier: none.Date of event: unknown.Implant an explant dates: device is an instrument and is not implanted/explanted.Udi: (b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The review of the device history record(s) showed there were no issues during the manufacture of this product that would contribute to this complaint condition.There was no nonconformances generated during production.No service history review can be performed as part number 319.01 with lot number(s) 7614672 is a lot/batch controlled item.The manufacture date of this item is 15-nov-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department found issues with various depth gauges during sterile processing.Two (2) depth gauges for 2.0mm and 2.4mm screws had bent tips, a depth gauge for the 2.7mm and small screws had a piece missing and two (2) depth gauges for 2.0mm and 2.4mm screws had a metal piece broken off.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Note: the udi was previously reported in initial medwatch report #(b)(6).(b)(4).A service and repair evaluation completed for the complaint device.The customer reported the item was missing a part.The repair technician reported ¿missing parts¿ as the reason for repair.The complaint device is not repairable per the inspection sheet.The cause of the issue is unknown.The complaint device will be forwarded to customer quality.The evaluation was confirmed.The cause of the issue is unknown.The service and repair evaluation was confirmed.The complaint device was forwarded to synthes customer quality for additional investigation.A product development investigation was also completed for the complaint device (depth gauge for 2.7mm & small screws, part number 319.01, lot number 7614672).The device was received by synthes customer quality assembled, but missing the nose piece/nipple (subcomponent 319_01_1).The hooked probe is intact an undamaged.Drawings 319_01, (manufactured/current) for the device were reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of this device.The complaint condition was confirmed; however, a root cause could not be determined.Corrected data: patient involvement is unknown and patient information is not available for reporting.Date of manufacture is nov 11, 2011.(b)(4) patient involvement is unknown but no patient harm was reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional clarification: although the complained instrument conditions were discovered during sterile processing, it is unknown when these issues actually occurred.It is unknown if there was patient and/or surgical involvement.There was no report of patient harm.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5784278
• MDR Text Key: 49234615
• Report Number: 3003875359-2016-10410
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• 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: 7614672
• Other Device ID Number: (01)10886982189950(10)7614672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2011
• 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