MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 412.213S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent an explant surgery on (b)(6) 2018, with femoral neck system (fns) implants due to nonunion, total hip arthroplasty (tha) was performed.Originally, the patient was implanted with fns implants, on (b)(6) 2018.During the procedure, when the surgeon tried to remove the locking screw, the screw could not be rotated to the counterclockwise direction.After trying to rotate it several times, the locking screw head was stripped.A conical extraction screw was used, however, it broke and the broken piece remained inside the screw head.A carbide drill was used, but drilling around the screw head with the broken piece of the extraction screw could not be done properly.The bone around the screw shaft was drilled and removed the fns plate without removing the screw from it.A cable was wound around the drilled area of the femur.Then, bipolar hip arthroplasty was performed as scheduled.The procedure was successfully completed with a 30-minute surgical delay.Patient outcome was unknown, but the starting period of weight bearing will be delayed from the initial schedule.Concomitant devices reported: unknown fns plate (part #: unknown, lot #: unknown, quantity: 1), unknown carbide drill (part # unknown, lot # unknown, quantity 1) and unknown non-synthes cable (part # unknown, lot # unknown, quantity 1).This report is for one (1) lockscr ø5 self-tap l38 tan.This complaint involves three (3) devices.This report is 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Received by manufacturer: the incorrect date was inadvertently utilized in initial medwatch.The correct date is november 20, 2018.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

12/06/2018: updated event description: this complaint involves two (2) devices.This report is 1 of 2 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.Event : updated quantity from three (3) to two (2).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.A device history record (dhr) review was conducted: please note, this dhr review is for sterilization procedure only: part no.: 412.213s.Lot no.: l770177.Manufacturing location: selzach.Supplier: frueh ag.Release to warehouse date: 13.Feb.2018.Expiry date: 01.Feb.2028.Non-sterile 412.213 / l738807 was manufactured in mezzovico.Release to warehouse date: 22.Jan.2018.The device history record shows this lot of 80 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.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.Corrected number of devices involved and corrected concomitant device list.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

Concomitant devices reported: unknown carbide drill (part # unknown, lot # unknown, quantity 1) and unknown non-synthes cable (part # unknown, lot # unknown, quantity 1) this report captures intra-operative event of difficulty removing locking screw while pc-000334913 captures post-operative event of non-union.This complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8148957
• MDR Text Key: 129882023
• Report Number: 8030965-2018-58897
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819152342
• UDI-Public: (01)07611819152342
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.213S
• Device Lot Number: L770177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention