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 was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: dhr review for part# 319.006, lot# a4gf828, release to warehouse date: 06-jun-1997, expiration date: n/a, manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed there were no issues during the manufacture of this product that would contribute to this complaint condition.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 after cleaning process in hospital, sterile processing department notified that tip of depth gauge is broken into two pieces.No patient involvement.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the depth gauge (part number 319.006, lot number a4gf828).The subject device was returned with the complaint condition stating 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.This complaint is confirmed.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.Drawings for the device(s) 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.A 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.A review of risk assessment found the risk specific to the complaint condition adequately addressed.No product design issues or discrepancies were observed.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.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6041463
• MDR Text Key: 57931490
• Report Number: 2530088-2016-10294
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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: A4GF828
• Other Device ID Number: (01)10886982189943(10)A4GF828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/1997
• 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