MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.026S

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, an osteosynthesis with long trochanteric femoral nailing advanced (tfna) system was applied to surgery for femoral subtrochanteric fracture in which the great trochanter cracked longitudinally.Upon final checking using the image, it was noticed that the tfna helical blade had been positioned out of bounds.Initially, after deciding the insertion point of the blade, a guide wire was inserted and was confirmed to be inserted at the center of the femoral head by anterior-posterior (ap), and medial-lateral (ml) images.Then, a helical blade in question was inserted, the side stopping was done and an end cap was inserted.However, when the final check was done, it was noticed that the blade had been positioned out of bounds.The blade and the end cap were removed and the locking mechanism was released.After the insertion handle was re-connected, a guide wire was inserted followed by the insertion of the helical blade.The surgeon confirmed that the helical blade was properly positioned in the femoral head, then the surgical wound was closed.The surgery was successfully completed and was delayed by 60 minutes.There was no adverse consequence to the patient.Concomitant devices reported: tfna end cap (part# 04.038.000s, lot# 2l79397, quantity 1), locking screw (part# 04.005.534s, lot# l971780, quantity 1), locking screw (part# 04.005.530s, lot# l998222, quantity 1), unknown guide wire (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) 10mm/125 deg ti cann tfna 360mm/right - sterile.This report is 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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 26-jul-2018, expiration date: 01-jul-2028, part number: 04.037.026s, 10mm/125 deg ti cann tfna 360mm/right- sterile, lot number: h690076 (sterile), lot quantity: 5.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: component parts were not reviewed because the reported complaint condition of ¿helical blade positioned out of bounds¿ was not related to breakage of any component of the nail, therefore, dhr review of the raw material(s) would not be relevant to the reported condition.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: 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8734737
• MDR Text Key: 149220210
• Report Number: 8030965-2019-65733
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649804
• UDI-Public: (01)07611819649804
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.026S
• Device Lot Number: H690076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Patient Sequence Number: 1