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

Catalog Number 319.06

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted/explanted.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, a review of the s&r service history review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the service and repair department documented that the ring for the depth gauge for mini screws xl is lost.No other information provided.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Service history review was performed: part no:319.06, lot no: 4658125, no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 25-sep-2003.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service evaluation was performed.The investigation of the complaint articles has shown that: the customer reported the ring was lost.The repair technician reported the tip was worn and burred.Burred is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on (b)(4) 2015.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

A product investigation was completed: the returned device shows light use during its 12 year lifespan.There are various discolorations on the graduated shaft and the measuring needle is undamaged.The threaded female collar that holds the device together is missing and was not returned.It is likely that this component was misplaced during sterile processing when the device was in a disassembled state.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.This complaint is confirmed.The relevant drawing for the device(s) was reviewed.No drawing issues or discrepancies were noted.The design is determined to be suitable for the intended use when employed and maintained as recommended.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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 MINI SCREWS XL
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5041920
• MDR Text Key: 24681844
• Report Number: 2530088-2015-10573
• 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,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.06
• Device Lot Number: 4658125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2003
• 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