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  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.(b)(4).Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.Without a lot number the device history records and service history record reviews could not be completed.The date of manufacture is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the tip of a depth gauge had broken off and was missing.The reporter noted that, three days prior to discovery of the reported issue, the instrument was used without incident during a surgery.Subsequently, the depth gauge went through the sterile processing wash.When the reporter was inspecting the instrument, he noticed the tip was missing.There was no patient or procedural involvement associated with the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned instrument was evaluated at customer quality and the complaint conditions were able to be confirmed.Only the slider was returned that is not etched with the part/lot number but the device was identified as part 319.006 however the lot number is still unknown.The needle component had broken off and the ball bearing on the side of the slider was missing.The protection sleeve, needle, ball bearing, and body were not returned.Although the definitive root cause could not be determined, it is likely that consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.A visual inspection and drawing review were performed as part of this investigation.Replication of the complaint is not applicable as the complaint condition was visually confirmed.This complaint is confirmed.Per the 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system.The relevant drawing was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments¿ lot numbers and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.Although the definitive root cause could not be determined, it is likely that consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.During the investigation no product design or manufacturing issues or discrepancies were observed that may have contributed to the 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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6380658
• MDR Text Key: 69204953
• Report Number: 2520274-2017-10741
• Device Sequence Number: 1
• Product Code: HTJ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• 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