MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.950S

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Due to intra-operative issues, the device was 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.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 (b)(4) reports an event in (b)(6) as follows: it was reported that intra-operatively the scrub nurse was setting up the dynamic hip system plate (dhs) and lag screw on the table.The dhs screw did not fit into the barrel of the plate.They tried for five (5) minutes but it did not work.They had to use a new plate and screw to continue the case.No information available about patient condition and outcome.(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (dhs/dcs screw, part number 280.950s, lot number l548316).The subject device was returned with the complaint condition stating the screw grooves were damaged.The complaint is confirmed.The investigation of the dhs/dcs screw has shown that the positioning groove of the screw is damaged and widened up, this damage makes an insertion of the plate impossible.The manufacturing documents were reviewed and no complaint related issues were found.This lot of (b)(4) was manufactured in september 2017 and no other complaint for this part and lot number were determined.The relevant dimensions below the damaged groove were checked and no deviation was detected.No product related issue could be detected.The damage occurred post-manufacturing.It is possible 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 groove.In order 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.Checked dimensions with caliper per drawing (b)(4): outer shaft diameter below the groove.Specification 7.9mm 0/-0.05 / measured: 7.88mm = pass.Outer shaft diameter at the groove.Specification 7.9mm 0/-0.05 / measured: 8,06mm = damaged post-manufacturing.Distance flats at the shaft: specification: 7.15mm 0/-0.08 / measured: 7.12mm = pass device history record: part no.: 280.950s lot no.: l548316 manufacturing location: (b)(4).Release to warehouse date: 01.Sep.2017.Expiry date: 01.Aug.2027.No ncrs were generated during production.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgical delay of 5-10 minutes reported; procedure was completed successfully.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7113430
• MDR Text Key: 95461553
• Report Number: 8030965-2017-50608
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055469
• UDI-Public: (01)07611819055469(17)270801(10)L548316
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.950S
• Device Lot Number: L548316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1