MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Device is an instrument and is not implanted/explanted.Device history records (dhr) review was completed for part# 319.006, lot# 9874106.Manufacturing location: (b)(4), release to warehouse date: aug 19, 2015.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.Service and repair evaluation concluded that the customer reported the depth gauge was bent.The repair technician reported the tip was broken off and missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.The returned depth gauge (part 319.006) was received at customer quality (cq) with the measuring needle sheared off at the threads.The sheared off needle was not returned.Minor surface wear was noted which does not impact functionality.Therefore, this complaint is confirmed, but for the condition of broken rather than bent.Whether this complaint could be replicated is not applicable because the device was returned broken.Relevant drawings were reviewed during investigation.The depth gauge for 2.0mm and 2.4mm screws (part# 319.006) is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.A relevant dimensional analysis could not be performed at cq as the needle sheared off at its base (flush with the distal edge of the depth gauge body) and was not returned and the remaining proximal portion of the needle is retained inside the depth gauge body and inaccessible.Based on review of the dhr records there is no indication that any issues with material or material properties including material hardness contributed to the complaint condition.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped or damaged during sterile processing).There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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) 2018, patient underwent an open internal fixation (orif) of a pilon ankle.During the procedure, the tip of a drill bit broke in the patient while the surgeon was drilling.All the fragments of the drill bit were removed from the patient, except for the tip was left implanted in the patient.In addition to this, during the same procedure, the surgeon was measuring a screw hole for a screw with a depth gauge and somehow managed to bend the depth gauge.No delay was created due to either of these events.The surgeon was done measuring the screw hole when the depth gauge bent.The patient was reported to be in great condition following the procedure.Upon receipt of the depth gauge, during manufacturer's preliminary evaluation on apr 27, 2018, it was noted that the tip of the device was broken.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 2 of 2 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7477081
• MDR Text Key: 107364867
• Report Number: 2939274-2018-51969
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 9874106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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
• Patient Age: 55 YR