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

Catalog Number 319.006

Device Problems Material Fragmentation (1261); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the depth gauge is sticking and that the tip has broken off.The device problem was discovered post-operatively.There was no report of patient or surgical involvement; however, it is unknown when the damage occurred.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Event date: unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.A service history record review was attempted for the subject device.A service history review could not be performed as this is a lot controlled item.The manufacture date of this item is (b)(6) 2013.The service history evaluation is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: a manufacturing evaluation was preformed: one of each of the following was received: depth gauge (part # 319.006 | lot # 7446558 | mfg.Date: 08/2013).The returned depth gauges shows light use during its 1.5+ year lifespan.The hooked needle on the device is broken off at the base of the black body and was returned.The depth gauge is part of 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.Although the damage appears to be the result of excessive weight being placed onto the needle during sterile processing and does not appear to be the result of normal use; the exact cause could not be identified.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.

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the item was sticking and the tip was broken.The repair technician reported tip broken 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 2.0MM 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: 4804374
• MDR Text Key: 5895974
• Report Number: 3003787298-2015-10028
• 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: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 319.006
• Device Lot Number: 7446558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• 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