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

Catalog Number 319.006

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reported that the measuring needle is broken and the outer sleeve is missing on the depth gauge.No patient or procedure were involved.There is no additional information.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 investigation summary: the complaint condition for the depth gauge (319.006) with unknown lot number was likely caused by rough or improper handling during surgery or sterile processing; however, this complaint is not a result of any design related deficiency.The depth gauge (319.006) is an instrument routinely used in the 2.4mm lcp distal radius system.The device was returned and reported to have become broken and that the outer sleeve is missing.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.The outer sleeve was not returned with the device.It is likely that rough or improper handling during surgery or sterile processing has led to this complaint condition.The outer sleeve was likely misplaced during sterile processing.The balance of the device is still in fair condition showing some moderate wear.The associated 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.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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: 4730557
• MDR Text Key: 5585144
• Report Number: 2520274-2015-13445
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 04/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2015
• 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