MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.144S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient that was implanted with a trochanteric fixation nail-advanced (tfna) nail is scheduled to be revised to a total hip replacement due to cut-out of the tfna helical blade element.Originally, the patient underwent implantation of the tfna nail, locking screw, end cap and helical blade, on (b)(6) 2018.On (b)(6) 2018, the cut out implant has been removed easily however the revision surgery has been delayed due to infection at the site.The revision surgery has yet to be completed.There was no surgical delay.Patient outcome was unknown.Concomitant device reported: synream reaming rod 2.5 mm, short, l950 mm (part #: 352.032s, lot #: l914347, quantity: 1) this report is for one (1) 11mm/130 deg ti cann tfna 235mm/right - sterile.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

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.Date of implantation is an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is the same as date of implantation; an unknown date in (b)(6) 2018.Manufacturing location: monument; manufacturing date: october 04, 2017; expiration date: september 01, 2027; part: 04.037.144s; 11mm/130 deg ti cann tfna 235mm/right- sterile; lot: h467005 (sterile); -lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Sterilization control number (scn) 14196 supplied by ethicon (abq) was reviewed and determined to be conforming.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 ¿cut out of the helical blade element' was not related to breakage of any component of the nail, therefore, device history record (dhr) review of the raw material(s) would not be relevant to the reported condition.The manufacturing documents were reviewed, and no complaint related issues were found.Product was not returned; therefore, no further investigation is possible.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 or material 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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8121233
• MDR Text Key: 129024838
• Report Number: 8030965-2018-58660
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650527
• UDI-Public: (01)07611819650527
• 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,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.144S
• Device Lot Number: H467005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention