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

Catalog Number 319.006

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: dhr review for: part#319.006 lot#6765303.Release to warehouse date: (b)(6) 2011.Manufactured by synthes (b)(6).Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the outer tube of the depth gauge no longer slides smoothly, making one-handed measuring difficult.No patient or case involved.This issue was discovered during routine inspection.No additional information is available.This complaint contains one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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

Product development investigation has been completed.A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.The returned part was evaluated and the complaint condition was able to be confirmed.The depth gauge¿s body component slid roughly against the ball bearing of the calibrated slider.The complaint condition is confirmed as each depth gauge was received with the body component showing slight resistance against the calibrated slider component during use.However, this has not impaired the function of each device.The body components can still be moved through their full range of motion by hand without significant force.Relevant product drawing was reviewed.During the investigation no product design issues, discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No new malfunctions were identified.The 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system.Although the exact cause cannot be determined, the most probable root cause of the resistance between components is wear from use and repeated sterilization cycles over the life of the device.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6345491
• MDR Text Key: 67942517
• Report Number: 1719045-2017-10123
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)6765303
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 6765303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2011
• 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