MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE,DEPTH

Model Number 319.004

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The depth gauge for 1.3 mm and 1.5 mm screws (p/n 319.004, lot 6474182) was received showing the distal needle tip bent.The needle component was also loose and starting to back out from the slider, as the threads of the needle component are visible.The needle component and slider are not separated into two pieces.No fracture sites were observed.No other visual issues were identified with the returned components of the device.The complaint condition is confirmed for the depth gauge for 1.3 mm and 1.5 mm screws (p/n 319.004, lot 6474182) as the distal needle tip was bent.The needle component was also loose and starting to back out from the slider, as the threads of the needle component are visible, which supports the condition of broken.No definitive root cause could be determined.It is possible that the bent and loosening condition of the needle was due to rough handling, and / or unintended forces from normal/device use by the operator.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and / or preventative action is proposed.Device history lot: part # 319.004, synthes lot # 6474182, supplier lot # na.Release to warehouse date: 14 sep 2010.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Manufactured by synthes (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

Event Description

It was reported that on (b)(6) 2019, the stick on the end of the depth gauge for 1.3 mm and 1.5 mm screws was bent at the tip and loss at the point it connects to the stem.It was handed to sales consultant by a sterile processing technician.There was no patient involvement.This report is for one (1) depth gauge for 1.3 mm and 1.5 mm screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8910430
• MDR Text Key: 155194078
• Report Number: 2939274-2019-59948
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.004
• Device Catalogue Number: 319.004
• Device Lot Number: 6474182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2010
• 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