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

Service and repair department documented that during spd, the tip of a depth gauge for 2.0mm and 2.4mm screws was found broken.It is unknown if the tip was retrieved.No issues with the device prior to discovery.No case or patient involvement.Device is available for return.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: unknown.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A s&r service history review 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 service and repair evaluation was completed: the customer reported the tip of the gauge 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.A product investigation was completed: the complaint condition for the 319.006 lot number 7378713 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.Per the technique guide, the 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system.The device was returned and reported to have become broken in sterile processing.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 may 2013 and is two years old.The balance of the device is still in fairly good condition.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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 risk assessment adequately addresses the complaint event.It is likely that rough or improper handling during sterile processing has 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

Date returned to manufacturer.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.A service history maintenance review was performed.The investigation of the complaint articles indicates that the: service history review: lot #7378713 no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 13-may-2013.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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: 4737989
• MDR Text Key: 5890998
• Report Number: 1719045-2015-10255
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 7378713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• 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