MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 280.900S

Device Problem Material Deformation (2976)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 169.0 cms.Patient identifier not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Initial reporter telephone not available for reporting.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 a patient underwent a procedure to treat a femoral neck fracture on (b)(6) 2018 with plate and screws.During the procedure surgeon first used dynamic hip and condyler screw (dhs/dcs) lag screw on locking compression (lcp) plate, but there was failure as surgeon didn¿t notify the screw diameter.Several attempts were made to remove the screw.Then surgeon used another dhs/dcs screw with the plate.During the procedure the dhs/dcs connecting screw broke inside dhs/dcs screw.All broken off fragments were removed from the patient.Surgery was delayed for unspecified amount of time due to reported event.Procedure was completed successfully with no patient consequences reported.Patient outcome reported as good.Preliminary evaluation of the returned devices revealed that both lag screws were expanded and damaged.Concomitant devices reported: dhs/dcs lag screw 12.7mm thread/60mm (280.600, lot l261421, quantity 1), 130 degree lcp dhs plate standard barrel 3 holes/76mm (02.224.203s, lot l806668, quantity 1), dhs/dcs lage screw 14.0mm thread/90mm (280.490, lot 9882468, quantity 1).This report is for one (1) 12.7mm dhs/dcs lag screw 90mm.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: patient code 3191 used to capture additional medical/surgical intervention required.A device history record (dhr) review was conducted for part: 280.900s, lot: l047458: manufacturing site: (b)(4), release to warehouse date: 05.July 2016, expiry date: 01.June 2026: the device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed, and the used material was according to iso-5832-1 specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Pre-investigation statement: as described in the complaint description it was reported that during a procedure with screws and plate, the connecting screw broke.By this the returned dhs/dcs-screw was found damaged.Visual inspection: the investigation of the dhs/dcs screw has shown that the positioning groove on top of the screw and the outer thread are badly damaged.Furthermore, there mechanical damages upon the entire surface visible.Dimensional inspection: the relevant feature is deformed in a manner which prevents accurate measurement of the feature.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Summary: the investigation of the dhs/dcs screw has shown that the positioning groove on top of the screw and the outer thread are badly damaged.Furthermore, there mechanical damages upon the entire surface visible.By this the complaint is confirmed.The relevant feature is deformed in a manner which prevents accurate measurement of the feature.The damage occurred clearly post-manufacturing.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 did lead to the deformation of the groove and the other related damages.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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/90MM-STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7739538
• MDR Text Key: 115697666
• Report Number: 8030965-2018-55413
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055452
• UDI-Public: (01)07611819055452
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.900S
• Device Lot Number: L047458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 08/27/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 59