MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/80MM; APPLICANCE, FIXATION, NAIL

Catalog Number 280.800

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date and concomitant products: unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.(b)(6).A device history record (dhr) review was performed on part # 280.800, lot # 3125241: manufacturing location: (b)(4), manufacturing date: 14 april 2009: documentation of work order including (b)(4) (check instruction) have been sent from (b)(4).The review of the complete documentation and all test results on pa do not show any irregularities or reference to a nonconformance.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery after the dynamic hip and condylar screw (dhs/dcs) was attached to the insertion instrument, they screwed the lag screw in the femoral head.During this step, the connection of the lag screw and the insertion instrument was deformed.Due to this, it was not possible to move the plate over the end of the screw.The surgery was prolonged about 10 minutes.There was no patient harm as they changed the screw to complete the surgery.The surgery was successfully completed.Concomitant devices reported: plate (part # unknown, lot # unknown, quantity 1), insertion instrument (part # unknown, lot # unknown, quantity 1), this report is for one (1) dhs®/dcs® lag screw 12.7mm thread/80mm, this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The investigation has shown that the positioning groove of the dhs/dcs® screw is expanded and damaged.The review of the production histories revealed that this dhs/dcs® screw was manufactured in april 2009.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.All described nonconformities are post manufacturing.The type and extent of damage incurred indicate that the positioning groove has been widened up due to inadequate handling.In order to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the appropriate dhs/dcs wrench.Visual inspection: positioning groove expanded.Dhr no findings.Dimensions: failed due to the damage incurred; dimensions were checked randomly at the time of manufacturing with no issues documented that would contribute to this complaint condition.Material: no deviations to the specifications.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: DHS®/DCS® LAG SCREW 12.7MM THREAD/80MM
• Type of Device: APPLICANCE, FIXATION, NAIL
• 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: 6584175
• MDR Text Key: 75779055
• Report Number: 3009450863-2017-10012
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819012707
• UDI-Public: (01)07611819012707(10)3125241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.800
• Device Lot Number: 3125241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2009
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INSERTION INSTRUMENT (PART & LOT # UNKNOWN, QTY 1)