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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the tip of a depth gauge broke during sterile cleaning.There was no patient involvement.No additional information was available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a service history records review was attempted for the subject device.A service history review cannot be performed as this is a lot controlled item.The manufacture date of this item is 29-aug-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).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: date of actual event is unknown.Breakage discovered on (b)(6) 2015.Device is an instrument and is not implanted or explanted.(lot number): provided lot number of 99541990 is specific to an instrument set, not the part in question.Verification of actual lot number was obtained (7023970) via engineers.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the service history records has been requested and is currently pending completion.Device 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

Device was used for treatment, not diagnosis.Device was used for treatment, not diagnosis.(b)(4).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: an investigation summary was performed.The investigation of the complaint articles has shown that: the 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system ((b)(4)).The 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system ((b)(4)).The device was returned and reported that the tip had broken during sterile cleaning.This condition is confirmed; the measuring wire is broken at the base where it meets the rest of the depth gauge assembly rendering it incapable of measuring.It is likely that rough or improper handling during sterile processing has led to this complaint condition.The device was manufactured in 8/2012 and is over two years old.The balance of the device is still in fairly good condition showing some mild wear.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.The complaint condition for the 319.006 lot number 7023970 depth gauge was likely caused by rough or improper handling during sterile processing; however, this complaint is not a result of any design related deficiency.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 JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4748660
• MDR Text Key: 5886219
• Report Number: 3003787298-2015-10025
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7023970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/28/2015; 05/29/2015; 06/01/2015; 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2012
• 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