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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device broke in the sterile processing department; there was no patient involvement.Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No service history review can be performed as part number 319.006 with lot number(s) 6745769 is a lot/batch controlled item.The manufacture date of this item is august 24, 2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed part 319.006, lot 6745769: release to warehouse date: august 24, 2011.Manufacturer: synthes (b)(4).Review of the device history record (dhr) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.A non-conformance report was created for undersized major diameter of the thread feature on the needle component.As the complaint description notes that the needle failed, relevance to the complaint condition cannot be determined until the product is returned for investigation.The bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength.All subcomponent dhrs were reviewed and found to be without issue during the manufacturing process that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a depth gauge was discovered broken after being retrieved from the wash during sterile processing.On (b)(6) 2016, a staff member from the sterile processing department took the device out of the wash and removed the black plastic outer sleeve, the tip of the long, thin metal piece that attaches to the bone broke off.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.A product development investigation was performed on the subject device (part # 319.006, lot # 6745769).The depth gauge was reported to have a broken tip/needle, and it is confirmed since the device was received in multiple pieces.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approx.75mm in length) and was not returned.The slider is loose in the hollow body.The handle has various marks and scratches, and the laser marking on the shaft is clearly visible.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 storage.Although the exact cause cannot be determined, the most probable root cause for this complaint is excessive force exerted on the depth gauge by placing / dropping heavy instruments on top of the device during the sterilization process.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Service & repair evaluation- the device was received by service & repair, and the broken component was confirmed.Device was unable to be repaired and was sent to customer quality (cq).This particular depth gauge 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.Drawings were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The thickness of the needle is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length is determined so the slider can measure screws up to 40 mm.The material of the needle probe component (part # 319.006.03) is extra hard, which is an appropriate material for an instrument component of this type.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Non-conformance report (ncr) was generated during production, but upon review the bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength.Therefore this ncr is not relevant to the complaint condition.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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: 6125070
• MDR Text Key: 60875873
• Report Number: 1719045-2016-10850
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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: 6745769
• Other Device ID Number: (01)10886982189943(10)6745769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2011
• 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