MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS-SCR Ø12.5 L95 SST; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 280.950

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/20/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported on (b)(6) 2023, that during the procedure, at the time of placing the plate and when impacting the plate, it pushes the screw by drilling the femoral head into the acetabulum and reaching part of the screw to the pelvis.When the screw pitch is done, the key is removed from the dhs, the plate is passed through, and the caps are placed to introduce the plate; this does not enter when impacting.Then the caps are placed again, the plate is entered, and the impact begins to enter the plate and is fixed.When lightning was taken, the screw was outside the plate; it had drilled the femoral head and the acetabulum.To remove the screw and to re fracture the patient, the used material is left in a medical-grade paper bag and marked with a red ribbon, as shown in the pdf.This report is for one (1) dhs/dcs-scr ø12.5 l95 sst.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

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.H3, h4, h6 investigation summary: the radiographs were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the radiographs revealed that the dhs/dcs-scr ø12.5 l95 sst had cut through the femoral head, and, based on the angle of the radiographs, it appears to have reached into the acetabulum.The complaint condition could be traced to technique error and misalignment, as no additional bone damage is observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the dhs/dcs-scr ø12.5 l95 sst.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history part #: 280.950, lot #: 3077p44, manufacturing site: balsthal, release to warehouse date: 16-dec-2022.A manufacturing record evaluation was performed for the finished device 280.950 lot #3077p44, and no non-conformances were identified.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.

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.H3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The radiographs were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device visual analysis of the radiographs revealed that the dhs/dcs-scr ø12.5 l95 sst had cut through the femoral head, and, based on the angle of the radiographs, it appears to have reached into the acetabulum.The complaint condition could be traced to technique error and misalignment, as no additional bone damage is observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the dhs/dcs-scr ø12.5 l95 sst.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H4,h6.Part #: 280.950.Lot #: 3077p44.Manufacturing site: balsthal.Release to warehouse date: 16-dec-2022.A manufacturing record evaluation was performed for the finished device 280.950 lot #3077p44, and no non-conformances were identified.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-SCR Ø12.5 L95 SST
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BALSTHAL; dornacherstrasse 20; balsthal CO 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17666106
• MDR Text Key: 322469508
• Report Number: 8030965-2023-11073
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819012738
• UDI-Public: (01)07611819012738
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 280.950
• Device Lot Number: 3077P44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DHS 135° 4HO L78 SHORTBARREL SST
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR