MAUDE Adverse Event Report: SYNTHES USA DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.(b)(6).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.Service history review was attempted: part no.319.006 , lot no: unknown, no service history review can be performed because the lot number cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.A review of the device history records 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

Report from synthes europe reports an event in (b)(6) as follows: it was reported that during the cleaning process it was noticed that a depth gauge was missing a piece.It was confirmed that the depth gauge is made up of four pieces and appears a piece is missing.There was no patient or procedure involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device investigation summary ¿ one (1) device was received with two pieces missing.The external slider body and the tip protector were not returned.Although the exact cause is unknown, the complaint condition is likely the result of inattentiveness during sterilization, rather than the design or manufacture of the device.This complaint is 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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5225106
• MDR Text Key: 31499683
• Report Number: 2520274-2015-17263
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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