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

Catalog Number 319.04

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the service and repair department documented that the depth gauge for 2.0mm and 2.4mm screws and depth gauge for 2.7mm & small screws (x2) were not sliding smoothly.There was no negative impact to patient and no delay in surgery.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not reported.Event date unknown.Device is an instrument and is not implanted/explanted.Without a lot number the service history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the service 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.

Manufacturer Narrative

A product investigation was completed: the complaint condition for the 319.006 lot number 6111346 depth gauge, the 319.04 depth gauge with unknown lot number, and the 319.01 lot number 3078377 depth gauge was likely caused by numerous years of use and sterilization cycles; however, this complaint is not a result of any design related deficiency.Per the technique guide, the 319.006, 319.01, and 319.04 depth gauges are instruments routinely used in numerous systems including the 2.4mm lcp distal radius system.The devices were returned and reported to be no longer sliding smoothly while measuring.This condition is confirmed; for the 319.006 depth gauge.This condition is unconfirmed for the 319.01 and 319.04 depth gauges.The 319.006 depth gauge requires more force than would be expected to adjust the measuring mechanism.A scratching sensation can also be felt while moving the measuring mechanism.The 319.01 and 319.04 depth gauges, while worn, do not seem to have any trouble adjusting their measuring mechanisms.It is likely that numerous years of use and sterilization cycles have led to this complaint condition.The 319.006 depth gauge was manufactured in march 2009 and is over six years old.The balance of the device is in good working condition.The 319.01 depth gauge was manufactured april 2009 and is over six years old.The balance of the device is a bit worn but otherwise in good working condition.The balance of the 319.04 depth gauge is in fairly worn condition.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned 319.006 depth gauge does agree with the complaint description.The complaint condition for this device can be replicated.The condition of the returned 319.04 and 319.01 depth gauges does not agree with the complaint description.The complaint condition for this device cannot be replicated.It is likely that numerous years of use and sterilization cycles have led to this 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.

Manufacturer Narrative

Service history review: no service history review can be performed because the lot number is unknown and cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the item was not moving smoothly.The repair technician reported binding as 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.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.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL 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: 4650047
• MDR Text Key: 19636762
• Report Number: 2520274-2015-12449
• 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: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.04
• Device Lot Number: XXXXXNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• 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