MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED SCREW MEASURING DEVICE; GAUGE,DEPTH

Catalog Number 319.701

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.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.(b)(4).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.

Event Description

It was reported the cannulated screw measuring device was discovered to be broken.No patient or surgical involvement was reported.This report is for one (1) cannulated screw measuring device.This is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED SCREW MEASURING DEVICE
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7441697
• MDR Text Key: 106080130
• Report Number: 2939274-2018-51820
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982190321
• UDI-Public: (01)10886982190321
• 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
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2018
• 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