MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/120MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 280.200S

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is an unknown date in (b)(6) 2017.Device malfunctioned intraoperative.Device was not implanted/explanted.(b)(6).The device was 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 the surgery on an unknown date in (b)(6) 2017, it was noted that it was not possible to pass the dhs/dcs lag screw through the dhs plate.It was further reported that this was discovered before the screw/plate was inserted into the patient.The problem was resolved by changing the dhs/dcs screw.No adverse consequences reported to the patient.Concomitant device reported: dhs/dcs plate (part# unknown, lot# unknown, quantity 1) this report is for one (1) dhs/dcs lag screw 12.7mm thread/120mm-sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a device history record review was performed for the subject device: part number: 280.200s.Synthes lot number: l404457.Release to warehouse date: 08.May.2017 expiry date: 01.Apr.2027.Supplier: (b)(4), manufacturing site: (b)(4).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.Non-sterile: part number: 280.200.Synthes lot number: l367936.Release to warehouse date: 31.Mar.2017 manufacturing site: (b)(4).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.A product development investigation was performed for the subject device: the investigation of the dhs/dcs screw has shown that the positioning groove of the screw is damaged due to an inadequate handling.The review of the production histories revealed that this dhs/dcs® screw was manufactured in may 2017.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.A functional test with an available plate has shown that the screw could not be inserted into the plate.We assume 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 could led to the deformation of the screw.Please note, 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.The surgical technique 036.000.255 points out in chapter 10a the warning note: to avoid damaging the instruments and the implant, tighten the connecting screw securely.The measurable dimensions of the dhs/dcs screw were as far as possible checked and found to be in compliance with the technical drawings.Measurement outer diameter ø7.9: gage: 3-03-17585 tolerance ø7.9 0/-0.05 result: ø7.88 "pass".Measurement external dimension 7.15: gage: 3-03-17585 tolerance 7.15 0/-0.08 result: 7.13 "pass".The unknown dhs/dcs plate which was reported as related product could not be investigated, as article and lot number are unknown.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Dhr review, no issue.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/120MM-STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7168478
• MDR Text Key: 96993012
• Report Number: 8030965-2018-50103
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055315
• UDI-Public: (01)07611819055315(17)270401(10)L404457
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.200S
• Device Lot Number: L404457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1