MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 3.5MM 62162CORTEX SCREWS; GAUGE,DEPTH

Catalog Number 319.091

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: fsm/tray,surgical instrument.Device is an instrument and is not implanted/explanted.Device history records was conducted.The part is 319.091 and the lot number is 7930122., manufacturing location: (b)(4), manufacturing date: 02/17/2015, part#: 319.091, lot#: 7930122 (non sterile): depth gauge for 3.5 mm cortex screws.Lot was release to the warehouse on 02/17/2015.Work order (b)(4) was issued on 02/11/2015 for qty (b)(4).Design drawing number - (b)(4) rev d released on 7/8/2010.No ncrs 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.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 by a facility that the silver ball was missing on two depth gauges.A retractor handle broke.A reduction forceps with serrated jaw-ratchet the ratchet is loose.This report is 2 of 2 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 3.5MM 62162CORTEX 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5205809
• MDR Text Key: 30573333
• Report Number: 1719045-2015-10719
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• 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: 7930122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2015
• 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