MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A service history review could not be performed because the subject device is lot/batch controlled item.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Supplier: (b)(4).Date of manufacture/release to warehouse date: oct 23, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 the pin (ball bearing) is broken off of the slide of a depth gauge during routine inspection in sterile processing.There was no report of procedural or patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the pin (ball bearing) was broken off the slide.The repair technician reported the tip of the depth gauge broke off.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.A product investigation was completed: the complaint condition is confirmed but inconsistent with the reported condition as the needle is broken not the ball bearing.The depth gauge was received with the proximal portion of the needle broken off at the threads.This is where it connects to the calibrated body of the device.The distal portion of the needle component was received.A device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.This depth gauge is used for measuring 2.0mm and 2.4mm screws in various trauma (including veterinary) plating systems.It is listed in techniques guides for the distal radius, distal ulna, elbow system, forefoot/midfoot, distal fibula, distal humerus, clavicle, rotation correction plate system and vet mini fragment system.The depth gauge was received with the proximal portion of the needle broken off at the threads.This is where it connects to the calibrated body of the device.The protection sleeve component was not received.The balance of the device shows surface wear consistent with use and is in functional condition.The ball bearing on the side of the calibrated body was found to be intact and fully functional.Thus, the complaint condition is confirmed but inconsistent with the reported condition as the needle is broken not the ball bearing.Replication of the complaint condition is not applicable as the device is already broken.Based on the date of manufactured the relevant drawings, reflecting the current and manufactured revision, were reviewed.The specified thickness of the needle is driven by the fact that the needle must fit into a minimum drilled hole of approximately 1.5 mm.The material of the needle component is 316leh (l=low carbon, e=extra h=hard) 316 stainless steel (ss), which is an appropriate material for an instrument component of this type.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The exact cause of the complaint condition cannot be determined.But the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve to protect the needle during transport and the outer body adds additional protection to the needle attachment point during use.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6269533
• MDR Text Key: 65570066
• Report Number: 1719045-2017-10043
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)7827531
• 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,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• 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: 7827531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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