MAUDE Adverse Event Report: SYNTHES OBERDORF DEPTH GAUGE FOR SMALL SCREWS; GAUGE,DEPTH

Catalog Number 319.09

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that two depth gauges for small screws and one depth gauge for 2.7mm & small screws are missing the caps and tips.The devices were found after the wash.There was no patient involvement and the issue was found outside of the operating room.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Service history review: lot 2145257/5156300: no service history review can be performed as this is a lot controlled item.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the knurled cap and tip were missing.The repair technician reported missing parts as the reason for repair.The cause of the issue is unknown.The following parts were replaced: depth gauge tip, knurled cap.This item was repaired, passed synthes final inspection and returned to the customer.The evaluation was confirmed.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.

Manufacturer Narrative

Additional narrative: the customer reported the knurled cap and tip were missing.The repair technician reported missing parts as the reason for repair.The cause of the issue is unknown.The following parts were replaced: depth gauge tip, knurled cap.This item was repaired, passed synthes final inspection and returned to the customer on (b)(4) 2015.The evaluation was confirmed.Follow up medwatch was requested for product investigation tab being completed.No new reportable information on that tab.No follow up medwatch was necessary.Devise was repaired and sent back to customer.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.

Manufacturer Narrative

An investigation review was performed.The investigation of the complaint articles has shown that:one of the following device(s) was received: depth gauge (part # 319.090 | lot # 2495372), depth gauge (part # 319.04 | lot # 3252561), the returned devices show signs of regular usage, with various scratches and marks.The devices have no functional damage but are missing the headpiece and knurled cap.The missing components were most likely lost in sterile processing while the device was disassembled.This complaint is confirmed, but is due to a handling error rather than the design of the instrument.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.This investigation is approved.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 SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH44 36; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4788447
• MDR Text Key: 5859690
• Report Number: 8030965-2015-10936
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.09
• Device Lot Number: 5156300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2006
• 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