MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.850S

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting facility.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: mar 8, 2016.Expiration date: mar 3, 2026.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(6) as follows: it was that during an unspecified surgery on an unknown date, the dynamic hip system/dynamic compression 12.7mm screw didn¿t fit into the plate.The screw was too big.The surgery was not delayed due to the reported event; however patient and surgical outcome were not provided for reporting.Concomitant medical products: plate (part# unknown / lot# unknown / quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product investigation was completed: the investigation of the returned dhs/dcs screw has shown that the positioning groove of the screw is damaged due to an inadequate handling.A functional test with an available plate has shown that the screw could not be inserted into the plate.It is likely that the connection between the wrench and the screw was not aligned as intended and therefore this occurrence in combination with a mechanical overload situation led to the deformation of the screw.The surgical technique guide give guidance to prevent such occurrence and 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 wrench 338.300.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.No product fault could be detected.On previous follow up report, date was reported as april 04, 2017, but should have been march 30, 2017.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/85MM-STERILE
• Type of Device: APPLIANCE, 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: 6451418
• MDR Text Key: 71487809
• Report Number: 3009450863-2017-10006
• Device Sequence Number: 1
• Product Code: KTT
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.850S
• Device Lot Number: 9852891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1