MAUDE Adverse Event Report: SYNTHES BALSTHAL DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS; INSTR,BENDING OR CONTOURING

Catalog Number 03.130.250

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

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

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review (b)(4) on 10-april-2017: dhr shows that (b)(4) was generated during production.Reason: width of component 60083047 (slider) out of specification.Affected lot 9743930 was put on hold in (b)(4) and 100% re-checked and documented.One part was scrapped due to out of tolerance of width and (b)(4) released.All documented results during manufacturing process were within specification and the 100% functional check during assembly at site (b)(4) showed no irregularities.Manufacturing site: (b)(4).Manufacturing date: 09.Dec.2015.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 during an open reduction internal fixation (orif) of the metacarpal, a depth gauge (for 1.3mm, 1.5mm and 2.0mm screws) was noted to not be measuring properly.Reportedly the device kept coming up with the wrong screw lengths when used to measure three (3) unknown 2.0mm cortical screws.A second depth gauge was readily available and used to successfully complete the surgery.There were no surgical delays, no harm to the patient and no additional medical intervention required.The returned device was noted to have a bent tip.Concomitant devices reported: cortical screw (part number unknown, lot number unknown, quantity 3).This report is for one (1) depth gauge.(b)(4).

Manufacturer Narrative

Product development investigation was completed.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint was not able to be confirmed.The distal tip of the measuring needle appears slightly bent, but nothing that would impair its function of accurate screw length measurement was observed.With the etched line/indicator slot of the slider set on 30mm etch line of the depth gauge body, the length of exposed needle to the distal needle flat measured 29.40mm (calipers ca592), which is within specification of 28.8mm - 29.8mm per depth gauge assembly drawing.Therefore, the complaint condition of measuring incorrect was not able to be replicated.The returned depth gauge for 1.3mm/1.5mm and 2.0mm screws is a reusable instrument available for use in the variable angle locking hand system to aid in screw length determination.Per technique guide, in order to measure, insert the depth gauge through the barrel of the reduction forceps (part# 03.130.291 to determine the screw length needed.The depth gauge is designed for one-handed use.Depth gauge assembly drawing was reviewed during this investigation.No product design issues or discrepancies were observed.No definitive root cause could be determined as the device measure within allowed tolerance.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 1.3MM/1.5MM AND 2.0MM SCREWS
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6534938
• MDR Text Key: 74260715
• Report Number: 3009450863-2017-10010
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 10886982075420
• UDI-Public: (01)10886982075420(10)9743930
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.130.250
• Device Lot Number: 9743930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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: 50 YR