MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Catalog Number 319.004

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the depth gauge was found in a drawer at the hospital and was reported to have missing parts.This device was not associated with known surgical event and there was no report of patient involvement.The device issue was initially determined to be non-reportable.The device addressed was evaluated by synthes service and repair and then forwarded to the synthes complaint handling unit for additional evaluation.Based on the results of the product development investigation, it was determined that this device and had difficulty sliding when attempting to measure depth.This issue was then re-evaluated and determined to be a reportable event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.A service history record review was attempted for the subject device.The review could not be performed because the device is a lot-controlled item.The manufacture date is jan 19, 2010 (released to warehouse date).A service and repair evaluation was performed for the subject device.The customer reported the item was missing parts.The repair technician reported the top of the probe was bent, the item was sticking, and the protective sleeve was missing.Missing parts is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on may 19, 2015 for additional evaluation.A product development investigation was also performed for the subject device.The returned depth gauge is used in a variety of systems to determine appropriate screw length during surgical procedures.The subject device, part number, 319.004, is used to measure depth when inserting 1.5 mm screws.The subject device had difficulty sliding when attempting to take a measurement.The associated drawing for the subject device was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Based on the state of the returned device and the procedures followed by sterile processing to sterilize the device prior to reusing it, the two most likely causes for the damage involve use of excess force and off-axis loading which can damage the devices over time, as well as components eventually wearing down, falling apart and getting lost during sterilization cycles.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 1.3MM AND 1.5MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4871117
• MDR Text Key: 5860725
• Report Number: 2530088-2015-10496
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 319.004
• Device Lot Number: 6303570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2010
• 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