MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS; GAUGE,DEPTH

Model Number 319.70

Device Problems Incorrect Measurement (1383); Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: depth gauge measure to 150mm but surgeon are using cannulated screws up to 180mm.It becomes an issue when they use these longer screws.The actual depth gauge has to be exchange for the depth gauge that measure up to 180mm (same product number).This report is 2 of 2 for (b)(4).

Event Description

Device report from canada reports an event as follows:.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.E1: reporter is a synthes employee.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: CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9578614
• MDR Text Key: 190632845
• Report Number: 2939274-2020-00136
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982190314
• UDI-Public: (01)10886982190314
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.70
• Device Catalogue Number: 319.70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Patient Sequence Number: 1