MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE, DEPTH

Catalog Number 319.091

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No known patient or surgical involvement.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is currently pending completion.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.

Event Description

It was reported that a ball bearing was notably missing from a depth gauge for 3.5mm cortex screws.The issue was discovered during sterile processing.There was no known patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: september 20, 2013.Part 319.091, lot 7486797: depth gauge for 3.5 mm cortex screws.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute 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

An investigation was performed on the subject device.A visual inspection and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The returned instrument is used during femoral, tibial, and humeral nail implantations for determining the length of locking screw, as addressed in relevant technique guides.The depth gauge was received with the silver ball bearing and spring on the side of the slider body missing and the distal tip slightly bent.The laser marking on the shaft is clearly visible.Thus, based on the received condition, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the ball bearing and spring were not returned.Relevant drawings for the returned devices were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.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 3.5MM CORTEX 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5963838
• MDR Text Key: 55159719
• Report Number: 1719045-2016-10689
• 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,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: 7486797
• Other Device ID Number: (01)10886982190000(10)7486797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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