MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COUPLING SCREW FOR EXTRACTION OF DHS BLADES; EXTRACTOR

Catalog Number 03.224.008

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during hardware removal procedure for right proximal femur on (b)(6) 2019, the tip of the coupling screw for extraction dhs blade has broken off in the implant.Surgeon attempted to remove the device, but was not able to adequately remove the screw in the dhs system in the femoral neck component.He said the screwdriver was of the incorrect size and this had happened before.The screw would not fit with any of the dhs insertion tools or removal tools.All the devices were explanted as planned and procedure was completed successfully.Concomitant device reported: unknown dhs blade (part# unknown, lot# unknown, quantity# 1); unknown dhs screw (part# unknown, lot# unknown, quantity unknown); unknown dhs plate (part# 02.224.224s, lot# l023173 , quantity# 1).This report is for one (1) coupling screw for extraction of dhs blades.This is report 1 of 3 for complaint (b)(4).

Event Description

Concomitant device reported: unknown dhs blade (part# unknown, lot# unknown, quantity# 1); cortex screw (part# 214.038, lot# l109010, quantity 1); cortex screw (part# 214.040, lot# 9894161, quantity 1); cortex screw (part# 214.040, lot# 9700520, quantity 1); cortex screw (part# 214.042, lot# 9903675, qty 1); lcp dhs plate (part# 02.224.224s, lot# l023173 , quantity# 1); dhs/dcs-scr ø12.5 l100 octagonal-coupl s (part # 280.301, lot # unknown, qty 1); screwdriver (part# unknown, lot# unknown, quantity# 1).

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 product investigation was conducted.Visual inspection: the fragment of an connecting screw is stuck in the received dhs/dcs screw.Based on the complaint description it can be assumed that this fragment belongs to the connecting screw 03.224.008.Only this fragment of the connecting screw was returned, the rest of the screw is missing.The fracture face is corroded and the microscopic view has shown that the fracture face is homogenous, which indicates material conformity.Dimensional inspection: the fragment is stuck within the bore of the dhs/dcs screw and cannot be removed.Thus the relevant dimensions cannot be verified as the fragment is not accessible.Drawing/specification review: the lot number of the connecting screw was not provided, therefore a review of the manufacturing documents is not possible.The dhs/dcs system surgical technique (036.000.255 dsem/trm/1114/0221(5) 02/17) was reviewed.Based on that is the connection screw for extraction of dhs blade part 03.224.008 used together with the extraction instrument for dhs blade part 03.224.005.Investigation conclusion: the complaint is confirmed for the connection screw as the screw is broken as described.During the evaluation it was not possible to confirm the part number as the shaft of the screw was not returned and as the dimension could not be verified as the fragment is stuck within the dhs/dcs screw.Based on the provided information was the broken screw the part 03.224.008, which is the connecting screw for the dhs blade extraction and not for the dhs/dcs screw extraction.Based on that we can only assume that for any reason the incorrect instruments were used for the extraction of the received dhs screw and that this did contribute to the breakage of the connection screw.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: COUPLING SCREW FOR EXTRACTION OF DHS BLADES
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9513595
• MDR Text Key: 188690049
• Report Number: 8030965-2019-71400
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819193642
• UDI-Public: (01)07611819193642
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 12/09/2019

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: 03.224.008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LCP DHS-PL 135° 4HO L92 STANDBARREL SST; UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE; UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR