MAUDE Adverse Event Report: SYNTHES BRANDYWINE 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 Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that: dhr review for: no service history review can be performed as part number 319.006 with lot number(s) a4gq663 is a lot/batch controlled item.The manufacture date of this item is 22-dec-1997.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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 during a set inspection the needle was found to be broke off on the depth gauge for 2.0mm and 2.4mm screws.There was no patient or case involvement.The sales consultant states that this is field equipment and did not give hospital account number.This complaint has 1 device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing review was performed for part: 319.006 lot: a4gw663.Manufacturer/supplier: (b)(4) release to warehouse date: 23-dec-1997: a material review record was generated for the needle component (319.006.3v lot a4-g-p747) for a lack of material cut on one (1) unit and debris in thread preventing the go gauge from making more than one turn on five (5) units.The items were reworked and all units passed final inspection.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device.One depth gauge for 2.0mm and 2.4mm screws was returned for investigation.The part 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 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.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 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.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.Drawing 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 (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) 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 316ss, 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.Calipers were used for all dimensional inspections/ measurements.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.The design is determined to be adequate for its intended use when used and maintained as recommended.Maintenance review was initially reported.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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6140117
• MDR Text Key: 61294377
• Report Number: 2530088-2016-10332
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

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: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: A4GQ663
• Other Device ID Number: (01)10886982189943(10)A4GQ663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/1997
• 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