MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 14.0MM THREAD/95MM; APPLIANCE,FIXATION DEVICE,PROXIMAL FEMUR

Catalog Number 280.495

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem Not Applicable (3189)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 169.0 cms.Patient identifier not available for reporting.Additional product code: ktt.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) 14mm dhs/dcs lag screw 95mm.This is report 2 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.A device history record (dhr) review was conducted for part number: 280.495, lot number: h106232: part mfg date: 25-may-2016, part exp.Date: n/a, manufacturing location: depuy synthes ¿ elmira: dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot# h106232 of dhs/dcs lag screw was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material dhr revealed this lot met all specifications with no non-conformances or rework noted.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 is damaged and widened up.Dimensional inspection: checked dimensions per relevant drawing for outer shaft diameter below the groove and is within the specification.Checked dimensions per relevant drawing for outer shaft diameter at the groove and is not within specification due to post manufacturing damage.Distance flat surfaces below the groove was measured and is within the specification.Distance flat surfaces at the groove was measured and is not within specification due to post manufacturing damage.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused 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 of the screw is damaged and widened up, this damage makes an insertion of the plate impossible and the complaint is confirmed.The relevant dimensions below the damaged groove were checked and no deviation was detected.No product related issue could be detected.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.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 14.0MM THREAD/95MM
• Type of Device: APPLIANCE,FIXATION DEVICE,PROXIMAL FEMUR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7739489
• MDR Text Key: 115704333
• Report Number: 8030965-2018-55412
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819769250
• UDI-Public: (01)07611819769250
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.495
• Device Lot Number: H106232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 08/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 59