MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.228S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The 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.(b)(4).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 or Problem Description
Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) a long trochanteric fixation nail advanced (tfna) was inserted with a lag blade in the femoral head and distal locking was completed.On viewing the final x-rays, it was discovered the lag blade had missed the nail.This was subsequently removed, the jig and handle were reconnected, and a new blade was inserted.Concomitant devices: locking screw (part: 04.005.528s, lot: unknown, quantity: 1), locking screw (part: 04.005.530s, lot: unknown, quantity: 1), insertion handle (part: unknown, lot: unknown, quantity: 1), tfna helical blade (part: 04.038.390s, lot: 10l0160, quantity: 1), guide (part: unknown, lot: unknown, quantity: 1), k-wire (part: unknown, lot: unknown, quantity: unknown).This report is for a 12mm/125 degree titanium (ti) cannulated tfna nail.This is report 5 of 5 for (b)(4).
Additional 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- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: monument manufacturing date: 16-aug-2019 expiration date: 01-aug-2029 part number: 04.037.228s, 12mm/125 deg ti cann tfna 380mm/right - sterile lot number: 14l5269 (sterile) 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 ¿lag blade missed the nail¿ does not indicate breakage or failure of any component part, therefore, dhr review of the raw material(s) would not be relevant to the reported condition.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.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 or Problem Description
A long nail was inserted with a lag blade in the femoral head and distal locking was completed.On final xrays it was discovered the lag blade had missed the nail.This was subsequently removed, the jig and handle were reconnected and new blade was inserted.The patient passed away after the surgery.Concomitant device reported: locking screw (part # 04.005.528s, lot # unknown, quantity 1), locking screw (part # 04.005.530s, lot # unknown, quantity 1), unk - end caps: tfna (part # unknown, lot # unknown, quantity: 1).
Additional 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.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.
Additional 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.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 or Problem Description
It was further reported that the patient passed away following the surgery.

• Brand Name: 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9812740
• Report Number: 8030965-2020-01776
• Device Sequence Number: 643330
• Product Code: HSB
• UDI-Device Identifier: 10886982097149
• UDI-Public: (01)10886982097149
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 04.037.228S
• Device Catalogue Number: 04.037.228S
• Device Lot Number: 14L5269
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 03/10/2020; 04/13/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/11/2020; 03/19/2020; 04/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCREW 38MM; 5.0MM TI LOCKING SCREW 40MM; TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAIL INSERTION HANDLES
• Outcome Attributed to Adverse Event: Required Intervention