MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 42MM; APPLIANCE,FIXATION,NAIL

Catalog Number 412.215

Device Problem Device-Device Incompatibility (2919)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight 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 patient underwent an open reduction internal fixation procedure utilizing the femoral neck system (fns) on (b)(6) 2018.It was noted at that time that there was a gap between the distal end of the plate and the bone.Around (b)(6) 2018, it was noted that the neck bolt and anti-rotation screw had backed out.Patient was returned to surgery on (b)(6) 2018 for removal of the devices.During the procedure, surgeon attempted to remove the locking screw with a screwdriver but was unsuccessful.Surgeon stated the shaft of the screwdriver was too long.An extraction screw was then used in an attempt to remove the screw but was also not successful.Surgeon then used other tools such as pliers, causing a subtrochanteric fracture.As a tentative measure, the affected site of the subtrochanteric fracture was then fixed with a wire and the surgical wound was closed.A revision surgery to implant an artificial bone head was scheduled for (b)(6) 2018.Patient hospitalization is expected to be extended due to the revision surgery.Surgeon stated that callus had formed at the gap between the plate and the bone, causing the difficulty in removing the locking screw.Revision surgery due to device back out is addressed in (b)(4).This report addresses the intraoperative issue with the locking screw and plate.Concomitant devices reported: neck fix bolt l80 (04.168.280s, lot l692850, quantity 1), neck fix anti-rotation screw l80 (04.168.480s, lot l670531, quantity 1).This report is for one (1) 5.0 mm locking screw.This is report 2 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.Additional information provided.Part: 412.215; lot: l662088; manufacturing site: mezzovico; release to warehouse date: november 17, 2017.The device history record shows this lot 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.The affected parts and x-rays were forwarded to product development for evaluation.The locking screw (412.215) was returned with a damaged head.The recess and the outer threads are fully damaged from the extraction efforts with multiple tools (screwdriver - assumed the one from fns system 03.168.014, an unknown extraction screw and finally unknown pliers).The plier marks ¿ used apparently to cut the plate 04.168.000 ¿ are evident on the screw.Further conclusions cannot be drawn regarding the inability to remove the screw from the plate.No further malfunction can be identified.In summary and based upon the information provided, no product malfunction/failure can be identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch be filed as appropriate.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 42MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7851839
• MDR Text Key: 119402880
• Report Number: 8030965-2018-56159
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819125087
• UDI-Public: (01)07611819125087
• 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
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 412.215
• Device Lot Number: L662088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Date Manufacturer Received: 09/25/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR