MAUDE Adverse Event Report: SYNTHES MONUMENT 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.Device is an instrument and is not implanted/explanted.A service and repair evaluation was performed for the subject device.The customer reported the tip broke off.The repair technician reported the tip broke off the measuring device, and the protective sleeve was missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The service and repair evaluation was confirmed.The item was be forwarded to synthes customer quality for additional investigation.The results are pending completion.A service and repair history record review was attempted for the subject device but could not be completed because the device is a lot controlled item.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4); supplier: synthes (b)(4).Date of manufacture (release to warehouse date): jan 26, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 during the cleaning process, the handle with mini quick coupling was found broken and the depth gauge was found with a broken tip.There was no reported patient or procedural involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

(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

Device was used for treatment, not diagnosis.A product development investigation was performed.It was reported that the device was found to be broken during service and repair: depth gauge for 2.0mm and 2.4mm screws (319.006).Service and repair found the device to be unrepairable and it was forwarded to customer quality.The returned product was examined and the complaint condition was able to be confirmed.The exact cause of the complaint condition cannot be determined, but the condition is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6100408
• MDR Text Key: 59869374
• Report Number: 1719045-2016-10822
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

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: 7901265
• Other Device ID Number: (01)10886982189943(10)7901265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2016; 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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